A Deep Dive: GDUFA III Scientific Meetings

to outline today's event the webinar and its entirety will run approximately three and a half hours which includes a q a panel session and if you have questions now or during the webinar please enter those questions into the Q a chat pod and remember to indicate the speaker to whom the question is being addressed for example at lay we'll answer as many questions as time allows

it's our pleasure to welcome Dr Lee Zhang to introduce gedu for three meetings Dr zany is the deck director office of research and standards in the office of generic drugs next we'll welcome Karen bingston to present on gdufa 3 redesigned pre-submission meetings care invention is a supervisory regulatory health project manager and the office of research and standards in OGD and finally before I break Dr talbye

we'll present on good free post complete response letter of scientific meetings Dr Bai is a senior advisor office of bioequivalence and OGD please join me to welcome Dr Zhang thank you for the introduction good afternoon my name is lisen I'm the deputy director of The Office of research and standards ORS in the office of generic drugs OGD at the FDA thank you for your interest and

welcome to the sbia webinar on a deep dive gadufa 3 scientific meetings in today's webinar we will provide an in-depth look into the enhancements and new features of the following adufactory teleconference and meetings pre-submission meetings post-complete response letter crl scientific meetings product specific guidance tsg teleconference and PSG meetings both pre-submission and post submission PSG meetings for each meeting we will describe how and when to utilize

those meetings to support generic drug development and also provide clarification and the best practices in meeting requests and conduct these meetings are highlighted in this webinar because they are either redesigned with changes as compared to Godiva 2 or Yuli offered under gadufa 3. here is the layout of today's agenda following this introduction we will have four presentations to cover each meeting types in details the redesigned

pre-submission meetings by Karen benston from ois new post CIO scientific meetings by Dr Tobi from Office of bioequivalence new PSG teleconferences by kalio bicerago from ORS and new PSG meetings by Dr hizon Chang from office about equivalence following all these presentations towards the last hour of this webinar you will have a chance to ask questions we will have additional panelists from the office of generic drugs

in the office of pharmaceuticality to join the speakers to address your questions you may start to send questions through the Q a box during the presentations we look forward to your active participation we will conclude the webinar with the closing remarks by ORS director Dr Rob lamberger there are multiple ways that industry can seek guidance from the FDA and for FDA to communicate with the applicants

to facilitate generic drug development including guidances general or product specific guidances written communication includes control correspondences or general correspondences and Industry meetings in gadufa 2 a series of new meetings namely product development meetings pre-submission meetings and mid-review cycle meetings were started as part of the pre-ender program to assist prospective and applicants of complex products before the submission of an Ender to FDA complex products are in

general harder to develop generics these meetings are aiming to help improve Ender submission improve review efficiency reduce review cycles and accelerate access to complex generics in gadufa 2 the product developed meetings and pre-submission meetings have improved scientific advice during development and have facilitated pre-submission communication with the FDA for Enders having pre-ender meetings they will also entitled to the mid-review cycle meetings for update on the potential

review issues and next steps teleconferences have provided clarification to help resolve deficiencies the success of the pre-ended meeting program has led to additional scientific meetings under godufa 3. on September 30th 2022 the generic drug use of the amendments were re-authorized with Provisions that are in effect from October 1st 2022 through September 30 2027 also known as gadufa 3. 3 a number of enhancements and changes are

made to the existing generic drug programs pre-ender and end up process as it relates to Scientific meetings that help provide Clarity to the end of applicants in this diagram meetings continued from gdufa to are in white color and new meetings in Godiva 3 are in orange color overall there are more scientific engagements throughout the Ender cycle new meetings are added in the gadufa 3 with both

pre and post-submission enhancements to help move complex products and products that need FDA help in general towards approval at pre-end submission phase product development meetings continue with new change pre-submission meetings are redesigned to focus on key issues for review and assure assessment team participation during post submission and the review phase a new Option of a more enhanced scientific mid-cycle review meeting called enhanced ncrm is added

with a goal of resolving more substantive issues with a single review cycle with a gold date extension during post action phase a new post crl scientific meeting is established to engage scientific discussion and facilitate subsequent cycle approval in addition under godufa 3 PSD teleconferences and PSG meetings are introduced that can provide help and advice to applicants throughout the Ender cycle to discuss the potential impact of

PSG publication either new or revision on their development program if applicants have already commenced an interview will be study PSG teleconferences are used to triage the request and determine whether PSG meetings are warranted pre-submission meetings posterior scientific meetings PSG teleconferences pre-submission PSG meetings and post submission PSG meetings will be discussed in more details at today's webinar gadufa 3 scientific meetings throughout the end of cycle help

clarify regulatory expectations for prospective applicants early in product development assist applicants in developing more complete quality Solutions also promote a more efficient and effective Ender assessment process enhanced Communications through those meetings also provide targeted and robust advice aiming for meeting the standards for under approval thus reduce the number of assessment cycle required to apply obtain under approval teleconference and the meetings are two broad meeting types

as a meeting type teleconference is not a meeting to differentiate from the teleconference and The Godfather 3 meetings are narrowly defined as a face-to-face interactions that can be held either as a video conference or in person teleconference on the other hand is defined by the commitment letter as a verbal communication by teleconference by telephone all industry pre-ender or enter meetings are either teleconferences or meetings as

shown in the next slide as of a note teleconference is one of the meeting types as well as one of the meeting formats that will be discussed later this diagram shows schedule for three teleconferences on the left side and meetings on the right side this cycle review meeting post-cio clarification teleconference and the PSG teleconference are teleconferences under godufa 3. product development meeting pre-submission meeting enhanced mid-cycle

review meeting post crl scientific meeting pre-submission PSG meeting and the post-submission PSG meetings are meetings under gadufa 3. teleconferences are clarification in nature and meetings engage more scientific discussion in today's webinar we will cover one teleconference and four scientific meetings in details in terms of meeting format there are four meeting formats for scientific meetings as defined in the formal meeting guidance they are in person face-to-face

meetings video conferences teleconferences and written response only in-person face-to-face meetings are held in a hybrid format in which core staff participate in person at FDA with additional attendees participate virtually via Video Connection video conferences are fully remote in which all attendees participate from various remote locations via Video Connection teleconference a verbal communication by voice and written response only is for FDA providing responses in writing meetings

are typically held as in-person face-to-face or as video conferences fdme provided teleconference or written response only for meetings if requested by the applicant or if the meeting is granted at fda's discretion for 10 conferences there are only two meeting formats teleconference or written response only when requested or agreed to by the applicant we noticed that some applicants may take video conference and teleconference as the same

however we would like to clarify that undergradufa 3 video conference and teleconference are two different meeting formats they are not the same or interchangeable although FDA may use the same platform for example Zoom to conduct teleconference and video conference little conferences allow for both audio and visual communication for scientific meetings like pre-ender meetings video conferences are typically more effective than teleconferences considering the complexity of the

scientific nature of the discussion video conference will not only facilitate discussion but also can serve as an alternate to in-person face-to-face meetings teleconferences on the other hand a voice only with no projection of presentation materials or use of video camera teleconferences are more appropriate for discussing clarification questions there are also specific leading types that are strictly teleconference for example PSG teleconferences applicants should request the desired

meeting format in the meeting request considering the different meeting format options available for the type of the meetings they are requesting and ask for the format that suits their needs do not request a teleconference if you want a video conference FDA will confirm the meeting format at the time of granting the meeting if a meeting is granted as a teleconference it will be voice only with

no projection of the presentations or use of the camera and will not be converted to a video conference on the meeting date occasionally a scientific meeting granted as video conference may be conducted as a teleconference if the applicant specifically requests a teleconference due to technical logistical difficulties or if upon reviewing fda's preliminary responses the applicant deems the questions remained are clarification in nature during the covid-19

pandemic in-person face-to-face meetings have been conducted in virtue with video conferences now covid-19 public health emergency ended on May 11th last week since March 27 2023 FDA has resumed the in-person face-to-face meetings for Ender applicants were then faced in approach starting with two pre-ender meetings that is product development meetings and pre-submission meetings applicants can request in-person face-to-face meetings for these two meeting types for these two

meeting types FDA May Grant in-person face-to-face meeting if applicant requests and if the meeting request meets the criteria for granting as of today all other scientific meetings under gadufa 3 will be default to video conference if in-person face-to-face meeting is requested when FDA will resume in-person face-to-face meetings for these other scientific meetings undergradufa 3 will be determined and announced in the future in-person face-to-face meeting requests

may be limited by facility capacity and logistical considerations in these situations video conference will be the default option requests for an in-person face-to-face meeting must be part of the initial meeting request package received as I mentioned earlier as of today in-person face-to-face meeting requests for other scientific meeting types under Godiva 3 if granted will be held fully virtually existing meetings received or scheduled before March 27

2023 will not be converted to the in-person format all in-person face-to-face meetings will be an in-person and the video conference hybrid in-person face-to-face meetings will be held with just the core participants from FDA with industry participants from FDA it is likely to be project managers meeting chair subject matter experts with an anticipated primary speaking role or other participants will be removed via video and audio connection

here is the challenge question starting March 27 2023 what kind of meetings can then and the applicant request as an in-person meeting a product development meetings B pre-submission meetings C post crl scientific meetings D A and A B and the E all of the above the correct answer is D A and B at this time only product developed meetings and pre-submission meetings may be granted as

an in-person meeting if it is requested by the applicant and if the meeting request meeting the granting criteria in summary multiple enhancements are added to the industry meetings under the doofer 3 to provide input throughout the product life cycle with more meetings in different situations more transparency and more efficient development and the decision about complex generics FDA developed this schedule for 3 teleconference and meeting infographic

to help navigate through various t-cons and meetings based on end of stages and product complexity here are some resources for additional information two guidances are the most relevant to the gadufa 3 meetings covered today are highlighted in yellow although mid-cycle review meetings and enhanced middle cycle review meetings are not covered in today's webinar you may find a YouTube video presentation from the FDA that provides additional

details on these two meetings thank you for your attention you may start to send questions through the Q a box during the presentations we look forward to your active participation thank you thank you for the introduction and hello to all those joining us today again I'm Karen Bankston and I'll be presenting an overview of the pre-submission meeting pre-submission meetings although not a new reading type were

redesigned under godufa 3. during the presentation I will cover the purpose and scope of the redesigned pre-submission meeting new timeline and changes to the overall meeting process and information on what should be included in your meeting package and when where and how to submit your request for a pre-submission meeting the pre-ended program was first introduced in godufa 2 and is designed to facilitate the approval of

complex generic products by clarifying regulatory expectations for prospective applicants early in product development assisting applicants developing more complete submissions promoting a more efficient and effective and assessment process and ultimately reducing the number of assessment Cycles needed to obtain a and d a approval the definition of a complex product did not change from gdu Fatu to godoofa three according to the definition in the commitment letter a

complex product generally includes one or more of the following features complex active ingredients formulations dosage forms routes of administration or a complex drug device combination product other products can be considered complex when there's complexity or uncertainty concerning the approval pathway or a possible alternative approach would benefit from early scientific engagement pre-ended meetings are only one part of the pre-ended program along with control correspondence product specific

guidance and could do for research pre-ended meetings which include product development and pre-submission meetings were introduced to facilitate pre-submission Communications between FDA and prospective applicants related to complex products and or complicated drug development questions although there were no changes to the product development meeting in gdufa 3 the pre-submission meeting was redesigned with a new purpose scope and shorter overall timeline in the subsequent slides I'll go

through these changes in more detail you could do for two pre-submission meetings provided an opportunity for prospective applicants to discuss or explain the content and format of an upcoming and as submission now in godufa 3 it provides applicants the opportunity to present to the agency the unique or novel data or information that will be included in an upcoming and a submission such as formulation key studies

justifications methods used in product development and interrelationship of data and information in the Anda it's important to note that this meeting does not include a substantive assessment of summary data or full study reports by FDA and is not an opportunity to determine whether the Anda is acceptable for receipt for example the prospective and applicants should not request or expect guidance on whether certain components needed for

receipt consideration may be omitted from the Anda in the good do for three commitment letter FDA agreed to Grant a pre-submission meeting if a prospective applicant was granted a prior product development meeting for the same complex product prior product development meeting granted for the same complex product in any meeting format meaning whether it's granted as in-person face-to-face video conference teleconference or as a written response only

would meet the criteria for one FDA will grant a pre-submission meeting assuming that the meeting request and package are complete in addition if a prospective applicant cancels a meeting because they have received and are satisfied with the fda's preliminary response it would also meet the eligibility criteria FDA also agreed to Grant a pre-submission meeting when FDA believes in its sole discretion that a pre-submission meeting would

improve the Anda assessment efficiency respective and applicants do not need to have a prior product development meeting to request a pre-submission meeting however the FDA recommends that prospective applicants of complex products seek fda's input via a product development meeting prior to submitting a request for pre-submission meeting so that FDA has the knowledge of the prospective applicants development program at the time of the pre-submission meeting in

general pre-submission meeting requests for non-complex products will be denied however FDA May Grant a meeting for a non-complex product if FDA decides that the pre-submission meeting would improve the and assessment efficiency and also dependent on available resources in this image I want to highlight the changes to the pre-submission meeting Timeline under godufa 3 and also note some of the items that did not change during gadufa

2 FDA agreed to Grant a deny a meeting request within 14 days of FDA received and to hold the meeting within 120 days of granting the meeting for gadufa 3 FDA agreed to Grant or deny a meeting within 30 days of FDA receipt and hold the meeting within 60 days of FDA receipt resulting in an overall shorter meeting timeline there was no change to the timeline

for preliminary comments which are issued at least five days prior to the meeting scheduled date or for the meeting minutes which will be issued within 30 days of the meeting date it's recommended that a pre-submission meeting be requested about six to eight months prior to the anticipated and the submission it's recommended that you thoroughly review the revised guidance for industry on formal meetings between FDA and

and applicants of complex products under godufa for the most complete information on suggested content and format of your meeting package you will find the link to the guidance in this slide as well as in the resources slide at the end of the presentation your package should be submitted at the same time as your meeting request and in general high-level information is sufficient your meeting package should

not in general include any questions to the agency if you have questions related to your product development program those questions should be submitted in either a product development meeting request or as a control correspondence as appropriate in your pre-submission meeting package you should indicate whether you've had a prior product development meeting for the same complex product and provide the corresponding event ID or IDs if you've

had multiple pre-ended product development meetings and a summary of the advice provided if you've not had a prior product development meeting with the agency provide an explanation for why a pre-submission meeting should be granted also in your package you should include the estimated timeline for submission of your and D A and the unique or novel data or information that will be included in your end to

submission you also have the option to submit your meeting package in the format of a draft meeting presentation appendix B of the formal meeting guidance includes a suggested presentation outline template listing items that prospective applicants should consider including or addressing in their presentation this is not an exhaustive list so there may be additional items that you should consider including some examples of the type of information

that you should include in your meeting package and presentation when applicable include alternative bioequivalent study design to the PSG recommendation novel in vitro drug release testing methods new statistical method used for supporting bioequivalence novel or unique approaches to development manufacture or control strategy of the drug product novel bioanalytical methods used in the in Vivo bioequivalent study or a novel analytical method used in the in vitro

bioequivalent study if there are design differences identified in the user interface of the proposed product when compared to the reference listed drug if you did not previously have a product development meeting or do not have a pre-assigned and a number you should obtain one prior to submitting your request for a pre-submission meeting information on how to request a pre-assigned application number can be found using the

link included here pre-submission meeting requests should be submitted using the cedar direct next-gen portal also known as the portal when you're in the portal you will need to select the type of meeting that you are requesting which will be shown as an Anda pre-submission meeting you will then be asked to indicate if you've had a prior product development meeting with the FDA for the same product

if you indicate yes you will be prompted to enter the associated event ID of the product development meeting that was held within the first 30 days of receipt of your meeting request parallel Grant deny assessments are performed by both the office of generic drugs and the office of pharmaceutical quality however note that FDA will make one unified Grant denied decision if granting FDA will identify and

assessment team members who will attend the pre-submission meeting in addition in the grant letter FDA will identify additional topics that the prospective applicant should address during the meeting when applicable if denying FDA will provide the reason for Denial in the letter Grant deny letters will be issued by day 30 of receipt of your meeting request pre-submission meetings are offered as in-person face-to-face or video conference meetings

due to the nature of the meeting teleconference and written response only formats are not offered as of March 27 2023 prospective applicants can now request in-person face-to-face meetings for either product development or pre-submission meetings if a request meets the criteria in the gadu for three commitment letter FDA will generally Grant the requested meeting format however if FDA grants above and beyond the criteria in the gadufa

3 commitment letter FDA will determine the appropriate meeting format the meeting format and the scheduling information will be included in your meeting requests granted letter and the project manager from the office of research and standards will be assigned as your primary point of contact through the pre-submission meeting process FDA will generally not issue information requests for pre-submission meetings draft presentations may be updated up to 21

days prior to the meeting so that FDA May provide the preliminary Commons at least five days before the meeting date final presentations should be submitted at least 48 hours prior to the scheduled meeting FDA will issue the preliminary written comments no later than day 5 prior to the meeting but FDA May indicate that there are no comments to provide at that time preliminary comments should not

result in the cancellation of a pre-submission meeting pre-submission meetings will be scheduled to be held within 60 days of the FDA receipt date of your meeting request as we return to in-person face-to-face meetings for both product development and pre-submission meetings we want to remind everybody that at least two weeks prior to the scheduled meeting date you'll be asked to provide to the assigned meeting project manager

the following information the updated list of all your meeting participants including the name title and Company affiliation in addition you'll be asked for relevant information for any foreign National visitors participating in the meeting in person a foreign visitor data request form will be included in your meeting request granted letter for the pre-submission meeting and you will be required to complete one form for each foreign visitor

all visitors must present a valid government-issued photo identification on the day of the meeting foreign National visitors must present the password that matches the information provided to the project manager or their entry will be denied on the meeting date lawful permanent residents of the United States must present a valid LPR card other forms of identification will not be accepted pre-submission meetings are typically granted as 60-minute

meetings and prospective applicants presentations will help Orient the discussion during the meeting FDA attendees will include members of the and assessment team and participants in any prior product development meeting as applicable at the meeting FDA staff will identify items or information that should be clarified before submission of your Anda if the prospective applicant would like FDA to consider their meeting summary they should submit their meeting

summary within seven calendar days of the meeting date via the portal FDA will issue meeting minutes within 30 calendar days of the meeting date and the FDA issued meeting minutes are considered the official and final record of the meeting prospective applicant requesting additional clarification of the meeting minutes issued by FDA should contact the assigned FDA point of contact notify the agency in writing of any significant

differences in understanding regarding the meeting outcome within 10 days of receipt of the official meeting minutes if the minutes are determined to accurately and sufficiently reflect the meeting discussion the point of contact will convey this decision to the prospective applicant and the minutes will stand as the official documentation of the meeting if FDA deems it necessary to change the official minutes the changes will be documented

in an addendum to the official minutes and the addendum will also document any continued objections challenge question number one FDA recommends that a pre-submission feeding request be submitted how far in advance of the Anda submission a 12 months be six to eight months C 10 to 12 months or D two to three months the answer is b six to eight months prior to the end submission

challenge question number two which of the following statements is not true a and could do for three pre-submission meetings provide prospective applicants the opportunity to present unique or novel data or information that will be included in the Anda submission B for a pre-submission meeting FDA will not provide a substantive assessment of summary data or full study reports c a pre-submission meeting will be granted as a

teleconference or written response only if requested by the prospective applicant D the meeting package for a pre-submission meeting can be submitted in the format of a draft presentation the correct answer is C due to the nature of a pre-submission meeting meeting formats are only offered as either in-person face-to-face or as a video conference in summary pre-submission meetings have been redesigned for gdufa 3 with a new

scope and timeline the speeding provides prospective applicants of complex products the opportunity to present to the agency the unique or novel data or information that will be included in their upcoming and to submission FDA will identify members of the Anda assessment team to attend the pre-submission meeting and anticipates FDA staff that participated in a prior product development meeting will also be in attendance when applicable at

the meeting FDA will identify items or information that should be clarified before submission of the Anda FDA will grant or deny a pre-submission meeting request within 30 calendar days of the FDA received date and if granted hold the meeting within 60 calendar days of receipt a request for a pre-submission meeting should be approximately six to eight months before the anticipated and the submission date and it's

recommended that prospective applicants of complex products seek fda's input via a product development meeting prior to requesting a pre-submission meeting so that FDA has knowledge of your development program at the time of the pre-submission meeting included is a slide of references that may be helpful to you if you're considering to submit a pre-submission meeting thank you very much for your time and attention I'll be part

of the Q a panel later to answer any questions thank you good afternoon welcome to the godor 3 meeting webinar next I'll give you an overview of a new Godiva 3 meeting a post complete response letter crl sent to the meeting since October 1st 2022 and the applicants can request a post crl sent to the meeting for SDA to provide scientific advice on possible approaches to

address deficiencies identified in the crl related to establishing equivalence in today's presentation I'll walk you through several key aspects related to this meeting and share with you some advice based on the submissions so far I'll start my presentation with an introduction of computer 3 meetings particularly this new post-crl scientific meeting then clarify the purpose of this meeting followed by discussing its Grant denied decision criteria as

well as this meeting process and key timelines in the end I'll give you some ideas of the current state of this meeting request submission and share with you some advice based on what the agency has seen so far then I'll end my presentation with two Challenge questions for CE purposes this is an overview diagram for all Godzilla 3 meetings these meetings are grouped in three areas

first pre-ender submission second post and a submission but before any actions last post actions post crl scientific media occurs in the post-action stage and any Anna that's in complete response status as October 1st 2022 and meets the eligibility requirements is eligible to submit a meeting request the purpose of Medusa and the assessment meeting program is to provide targeted robust advice to an applicants as they work

to meet the standards for and approval in good verse 3 this new meeting post-crl scientific meeting has been added to the godifa program the purpose of this meeting is to provide an applicant's scientific advice on possible approaches to address scientific deficiencies identified in the crl related to establishing equivalence the post-crl authentic meeting is intended to discuss one or more of the topics listed in this blue

box as it relates to establishing equivalence first one a new equivalent study is needed to address the deficiencies in the study design identified in the crl second using an approach that's different from the submitted what's submitted in the NF for example a change in the study typed from a rival study to an individual study third a new comparative use human factor study or number four using

a new approach to demonstrating sameness of a complex active ingredient so if the questions are related to one or more of these topics and if it is for a complex generic product at the a will grunder meeting FDA will also Grant the meeting if in fda's judgment the request raises issues that are best addressed to be at the meeting and cannot be adequately addressed through control

correspondence FDA will communicate the grand denied decision to the applicant within 14 days after the receipt of the request and FDA will hold the post crl assigned to the meeting within 90 days after the meeting is granted please note that an end applicant may have a posterl teleconference to seek clarification concerning deficiencies identified in the crl prior to requesting this meeting however the applicant the end

applicant does not have to have had a posterl teleconference prior to requesting a posterior scientifically also and the applicants can request a post URL scientific meeting even if they have not had a product development meeting with the agency in the next three slides I'll discuss in details about the three scenarios about this meeting including will Grant's situation make Grand situation and maybe denial the situation for

the well-brained scenario as discussed on the previous slide FDA will grant the post crls scientific meeting request if the meeting request is for a complex generic product and the questions raised in the meeting request is related to one or more of the four topics presented here which is also shared on the previous different three commitment letter slide at the AMA Grant the post crl sent to

the meeting request using fda's judgment the questions or issues risks in the meeting request package are best addressed via the meeting process and cannot be adequately addressed through control correspondence again here we'll like to emphasize that this meeting is is intended to discuss any of these four main topics a new encrypted study to address the deficiencies a new proposed approach a new comparative use human factor

study or a new approach to demonstrating context API saying this on the other hand together let's take a look at the scenarios that fbma deny a posterl is enter the meeting request FDA may deny a post crl centerpie meeting request because the product does not meet the criteria for a complex product for example complex API or complex formulation drug device combination product Etc or an fda's

judgment the questions submitted in the meeting request can be actively addressed through control correspondence or the meeting request does not discuss one of the four topics discussing the Godiva three commitment letter as it relates to establishing equivalence okay now let's together review some important timelines for this new good number three meeting post crl scientific meeting they're listed on this slide and colored in red first FDA

will make Grand or deny decision within 14 days after the receipt of this posterl ascended meeting request second if granted FDA will hold the meeting either in person or video conference or have a teleconference within 90 days after the meeting is granted if you request a written response instead the written response will be issued within 90 days after it is granted as well here please note

that it is 90 days after the meeting is granted not 90 days from the meeting request is submitted so number three if granted five days prior to the meeting with the applicants FDA will also issue a preliminary response to applicants questions and lastly the final meeting minutes will be issued within 30 days of the meeting or teleconference please note that if a due date falls on

a weekend or federal holiday it will be moved to the preceding business day once a grant denied decision has been made by FDA the applicant will either receive a denial letter if the posteriorl center the meeting request has been denied on the denial letter reasons for denying the meeting requests will be stated if the meeting request has been granted the applicant will receive a grant letter

from FDA on which FDA will stay the meeting date meeting time or a go day for providing a written response if a written response is to be provided as well as preliminary list of FDA attendees for the meeting and the decided format of the meeting which included in person face to face when this option becomes available in the future or video conference or Tender conference or

written response only here I'd like to draw your attention to the differences between a video conference and a teleconference Please be aware that a video conference includes both audio and visual communication between SDA and NF applicants at a video conference at a minimum core members who have the speaking roles are expected to turn on their cameras while speaking is it is relative is really needed and

the applicants May request to use presentation to support the discussion at the video conference but in those cases the decision should be discussed ahead of time with at their point of contact and the presentation materials should be shared with FTA ahead of the meeting we're going to discuss this aspect a little bit more in details in next few slides well for China conference it means video

only neither FDA or any applicant Representatives need to open their cameras while speaking no presentation will be used as a supporting two during the title conference so with that FDA advisors and applicants properly select the format of the meeting and indicate clearly in the meeting package that which meeting format is preferred this is to ensure a productive meeting with FDA now let's talk about what are

expected to be included in the meeting package in addition to the January information related to the Anna for example and the number drug product name iot information preparation objective of this meeting Etc a post crl scientific meeting package should clearly indicate that this is this is a post-crl scientific meeting request and include a brief statement indicating how the product meets the criteria for a complex product

it's applicable in addition the meeting package should clearly state which of the four criteria previously discussed on my slide that are related to establishing equivalence will be focused on in the meeting and provide sufficient data to support discussion also the applicants should clearly state that the requested format as I mentioned in the previous slide just like any other Godiva meetings a post URL scientific meeting can

be canceled as well for example the applicant May voice draw their meeting requests at any time based on their business or or other reasons or once received the preliminary written response comments and the applicant informs FDA that is questions have been adequately addressed by the preliminary written response comments or based on FDA newly issued product specific guidance and applicants feels that a meeting is no longer

necessary because the newly published PSD may help address the questions in the meeting package so they do not think there is a need to meeting with FDA for these questions anymore for post-crl scientific meetings FDA intend to provide preliminary written comments to the end applicants no later than five calendar days before the meeting this communication before the meeting can serve as a foundation for discussion or

as a final meeting responses however preliminary written comments should not be considered as final unless there is agreement between the applicant and FEA that additional discussion is not necessary for any questions if both agree that based on the preliminary written response Commons any particular questions are considered resolved we may dedicate the meeting discussion to the rest of the on resolved questions or as discussed in an

earlier Slide the meeting may be canceled because the applicant finds the preliminary written response comments are adequate to address all their questions here please notify that after receiving the preliminary written response comments the applicant should provide an updated agenda with this list of questions for discussion in order of priority no later than 48 hours before the scheduled meeting in general presentations by applicants are not needed

for this meeting because the information necessary for review and discussion should already be part of the meeting package however if you still plan to make a presentation during the meeting the decision should be discussed ahead of time with the FDA point of contact please keep the presentations brief in order to maximize the time available for discussion any presentation material should be shared with FDA point of

contact at least 48 hours prior to the meeting here I'd like to emphasize that the preliminary written response comments communicated by FBA should not generate the submission of any new questions and new questions will not be entertained at the meeting in general in order to have a meaningful and productive discussion in the meeting the discussion should focus on any remaining questions that have not been adequately

addressed by the preliminary written response comments or any clarification questions you may have based on the preliminary return response comments that FDA had shared after the meeting is held FDA will issue an official finalized menace to the end the applicant within 30 days fda's minutes are considered the official record of this meeting if the applicant believes there is a discrepancy in the minutes they may submit

their concerns in writing within 10 calendar days of the receipt of the official meeting minutes as of April 28 2023 FDA has received 11 Post crl scientific meeting requests seven meeting requests met the acceptance criteria and have been granted by FDA based on the submission of this new good difference 3 post crl authentic and meeting I'd like to share some advice with you first please note

that FDA will not pre-review any specific scientific data submitted in the meeting package so questions related to whether any submitted data is considered acceptable is outside the scope of this meeting second if any new study or new approach has been discussed in the meeting request FDA May comment on the general acceptability of this new study or new approach but the ultimate acceptability of the proposed new

study or new approach will be further assessed with additional relevant information upon the submission in the end Amendment what's that I like to end my presentation with two pieces of important references one is the guidance for formal meetings between FDA and and applicants of complex products on the bedoufa in October 2022 FDA published a revised version of this guidance by incorporating and Godiva's three related changes

to the formal meetings you may use this link here to add access this guidance the other reference is FDA good difference three reauthorization page here you'll be able to find all the different three related resources including negotiation public meetings commitment letter and related guidances and Maps Etc you may use this link on the bottom to access this page Here Comes The Challenge questions challenge question number

one is following statement true or false a post-crl incentive meeting request can only be submitted after course submitting a post-crl attended conference to the agency the correct answer is false you may submit a post crl Tech conference to clarify any deficiencies in the crl but you don't have to submit until crl type of conference before submitting a posterior lsntic meeting request to the agency challenge question

number two my application was submitted prior to October 1st 2022 but now is in CR status is my application still eligible to request post crl sent to the meeting the answer is yes any and the application regardless its submission date as long as it is in complete response status after October 1st 2022 is eligible to submit a post crl sent at the meeting if it meets

eligibility requirements for this meeting with that I'd like to thank you for your time and attention I'll come back during the Q a session to answer any questions you may have for this new victim history meeting post-crl Center for reading thank you thank you for the great presentations I will now enter into our break until 2 30 PM eastern time enjoy your break together with the

survey link moving into our next presentation Calio saraga will present on gdufa 3 product specific guidance teleconferences Kelly hope Sarah go was a senior regulatory health project manager in the office of research and standards in OGD and finally our final presentation will be on the gudu for three product specific guidance meetings by Dr hee son Chung Dr Chung is a lead pharmacologist in the division of

bioequivalence 1 office of Bio equivalents and OGD please join me to welcoming our first presenter Kelly Sergo good afternoon today I will cover bedufa 3 product specific guidance teleconferences a new format of communication with the FDA for the do for three our learning objectives for today are describe the PSG teleconference process flow and timeline break down the elements of pre-submission and post-submission PSG teleconferences explain when

what and how to submit your PSG teleconference request identify reasons for granting and denying your PSU teleconference describe how FDA will schedule and hold the PSG teleconference and finally explain canceling rescheduling the teleconference issuing FDA minutes and dispute of minutes process this diagram is an overview of the PSG teleconference process upon receipt of your PSG teleconference request FDA will conduct an assessment of the acceptability of

your teleconference package FDA will issue a grant or denial letter within 14 calendar days of receipt of your request if a PSG teleconference request is denied written notification will include an explanation of the reasons for your denial if granted an assessment team will meet to assess your teleconference request FDA will hold your PSG teleconference within 30 calendar days of receipt of your request or issue a

written response only letter if it's granted in that format PSG teleconference minutes are issued within 30 calendar days of holding your teleconference to note FDA will not issue an information request or preliminary written comments for a PSG teleconference PSG teleconferences a PSG teleconference provides a format for applicants to obtain fda's feedback on the potential impact of a new or revised PSG on an applicant's development program

criteria for submission are when a new or revised PSG is published on or after October 1st 2022 and an applicant a prospective applicant has commenced or completed an in-vivo bio equivalent study commenced means the study protocol has been signed by the study sponsor and or contract research organization a PSG catalog conference is not intended for in-depth scientific discussion this type of PSG meeting will be discussed

in the next presentation a PSG teleconference can be requested in the preanda phase and after and a submission a PSG teleconference can be requested for a complex or non-complex drug product this slide provides a summary of the PSG teleconference time frame and process 14 calendar days to Grant or deny your requests from receipt keep in mind the commitment letter does not define a time frame for

the grant or denied decision Health conference will be held within 30 calendar days of receipt keep in mind the 30-day teleconference hold date applies to requests and complete packages submitted within 60 days after publication of a new or revised PSG your request must meet criteria set forth in the draft guidance guidance meetings between FDA and a NDA applicants under godufa which was published in February of

2023. there is a link to the guidance in the references at the end of the presentation the duration of a teleconference is 60 minutes the format is either teleconference or written response only if a request meets criteria in the gadufa 3 commitment letter for a PSG teleconference FDA will generally grab the requested format if the request does not meet criteria it's fda's discretion to Grant written

response only or direct the applicant to submit a control correspondence instead of holding a PSG teleconference keep in mind that during an Anda assessment cycle a controlled correspondence may only be submitted if an applicant seeks further feedback from FDA after a PSG teleconference has been held PSG teleconference overview an applicant can request only one PSD teleconference for each new or revised PSG posted a teleconference means

a verbal communication by telephone which is Audio Only FDA will not share documents or video if a written response only format is granted responses will issue in lieu of holding a teleconference as previously stated FDA will not provide preliminary written comments or information requests when should I submit a PSG teleconference request when FDA issues a notice in the Federal Register announcing the availability of new and

revised psgs posted on the PSG webpage a link to the PSG webpage is provided for reference generally FDA publishes psgs and batches on a quarterly basis FDA recommends an applicant submit a PSG teleconference request within 60 calendar days after publication the date recommended of the new or revised PSG the publication date of a PSG is the day the PSG is posted on the PSG webpage date

recommended will be listed on the PSG webpage and is highlighted here for reference when to submit PSG teleconference request continued the key takeaway we want to emphasize for submission is when FDA publishes a new or revised PSG that introduces or revises a recommendation related to an in Vivo be study and the applicant has already commenced or completed an in vivobe study for post submission PSG teleconferences

FDA also intends to offer opportunity for a PSG teleconference for the following when FDA publishes a new PSG which includes a recommendation to conduct an in-vivo be study and the Anda applicant did not conduct an in-vivobe study FDA offers the ability to request a PSG teleconference for this scenario even though such applicants may not meet all the criteria in the gadufa commitment letter another criteria is

when FDA publishes a revised PSG which includes a recommendation to conduct an in-vivobe study the previous PSG did not include a recommendation to conduct an in-vivo be study and the Anda applicant commenced or completed the in vitro be study or studies that were either recommended by FDA in the previous PSG or that the amda applicant decided to pursue after a prior product development meeting when not

to submit a post submission PSG teleconference when the PSG is revised to include an in vivobe study as an additional option to begin vitro B study that was recommended in the previous PSG and the applicant followed the recommendations in the previous PSJA which should be included in your teleconference request and package I'm not going to go over a complete list of all information that is needed

in your submission I'm only going to highlight some key features please refer to the guidance in gdufa 3 commitment letter for additional details on what to provide in your submission please include in your submission a valid pre-assignment A and D a number or a and d a number include the type of meeting you are requesting and in this case it would be a PSG teleconference this

information should be identified in your cover letter the month and year the current PSG was published a description of how your study differs from the recommendation in the PSG and if applicable a statement indicating that the in Vivo study is impacted by the new oravides PSG signature page of the relevant in Vivo be study protocol that has been signed by the study sponsor and or contract

research organization in the background section include a brief history of development program the status of your product development the purpose and objectives your meeting package should provide information for FDA to assess the utility of the package and identify appropriate staff the requested format and proposed agenda outlining how the 60 Minutes will be allocated for each agenda item keep in mind the meeting package should be received

at the time of the meeting request how should you submit a pre-submission PS3 teleconference submit your pre-submission request and package for a pre-submission teleconference electronically through the cedar direct next-gen collaboration portal identify your submission as a PSG teleconference in your cover page in this slide I will highlight key features in the portal for your pre-submission teleconference submission it's highlighted in red an applicant will need to

provide an Anda pre-assignment number keep in mind this is only needed for pre-submission teleconferences an applicant will also be required to select the type of request and again in this case a pre-submission PSG teleconference would be selected an applicant will also provide a brief description of the teleconference for example you may want to use the teleconference to obtain agency feedback on the potential impact of a

new or revised PSG on your drug development program continuing with pre-submission teleconferences PSG teleconferences are only valid for PSG recommendation dates for psgs posted on or after October 1st 2022. an applicant will also need to add a protocol signature date keep in mind the signature date must be before the PSG recommendation date how to submit a post-submission PSG teleconference a post-submission PS3 teleconference should be submitted

once an Anda is in-house the request is submitted electronically through the Enterprise submission Gateway the request should be submitted as a general information Amendment and the cover page should identify the submission as a post PSG teleconference request I have provided a reference link to the ectd submission guidance your PSU teleconference request was granted what happens next FDA will provide written notification to the applicant of the

decision and format either teleconference or written response only scheduling information is provided in the grant letter or as soon as possible following the granting of your request 50a is providing written responses only instead of holding a teleconference FDA will notify the applicant of the written response only format FDA schedule is the teleconference by determining the date time length format and the expected FDA participants teleconferences are

scheduled within the gdufa 3 performance goals if teleconference request is received within 60 days of PSG publication teleconferences held within 30 calendar days of receipt of your request what happens if your teleconference request is denied if an applicant has not met criteria outlined in the guidance and commitment letter the PSG teleconference request may be denied some examples would include if the applicants in Vivo the e-study

started after the PSD was published or the request is incomplete an incomplete request for example would be if an applicant did not include the signature page signed by the study sponsor or contract research organization when FDA publishes a new or revised PSG which includes a recommendation to conduct an in vitro be study and the applicant has commenced or completed an in vivobe study submission of the

in Vivo B study is generally an acceptable approach for demonstrating be FDA recommends an applicant include supporting information with its Anda to justify the in-vivo approach used that deviates from the in vitro approach recommended in the PSG to demonstrate be to note if a teleconference request is denied written notification to the applicant will include an explanation of the reason for the denial is subsequent PSG teleconference

request is considered a new request an assigned new time frames the day of your teleconference teleconferences are typically one hour discussion will focus on how the applicants be studies differ from the studies recommended in the PSG FDA will not address or discuss any new data questions outside of the scope of the PSG teleconference FDA can provide general advice or recommendations and generally applicants will be asked

to summarize important discussion points agreements and action items to ensure Mutual understanding of meeting outcomes and action items PhD teleconference outcomes to obtain fda's feedback on the applicant's development program if additional clarification or discussion is needed after the teleconference FDA will recommend an appropriate path for future communication this may include controlled correspondences pre or post submission PSG meetings or other meeting types as appropriate to note

applicants should not submit multiple meeting requests or controlled correspondence at or around the same time with the same or similar questions the teleconference minutes teleconference minutes are issued within 30 calendar days after the teleconference applicants May submit their summary within seven calendar days of the meetings date FDA issued minutes are the official record of the teleconference dispute of teleconference minutes this was discussed in a previous

presentation by Karen Bengston so I will only highlight key issues as the process is the same for PSG teleconferences an applicant requesting additional clarification of minutes should contact their assigned FDA point of contact you should submit your concerns about the minutes in writing to FDA within 10 calendar days of receipt of the official minutes requests should only address issues that are regarding the minutes only if

an applicant needs to discuss additional issues that were not addressed in the teleconference we recommend submitting a control correspondence or a new meeting request but not a new PSG teleconference canceling your teleconference if a teleconference is canceled a subsequently request to schedule another teleconference will be considered a new request it will be at fda's discretion whether the teleconference should be canceled depending on specific circumstances examples

of these may include prospective and applicant or applicant withdraws the request the perspective and the applicant submits their and on or FDA refuses to receive the Anda to note if an applicant cancels the teleconference FDA will count performance goals as met if FDA cancels this will not count towards performance goals you have now reached our first challenge question within what time frame should an applicant submit

a PSG teleconference request after publication of the new or revised PSG 20 calendar days 30 calendar days 60 calendar days or 90 calendar days give you a few moments to figure it out and the answer is 60 calendar days as a reminder publication is the date recommended listed in the PSG webpage the Second Challenge question is which of the following statements is not true in general

FDA will issue preliminary written comments before PSG teleconference B requests are granted as a teleconference or written response only format c a pre-submission teleconference is submitted through the cedar direct next-gen collaborative portal or D submit concerns about the minutes in writing to FDA within 10 calendar days of receipt of the official minutes and the answer is a in general FDA will issue preliminary written comments before

a PSG teleconference FDA will not issue preliminary written comments for a PSG teleconference in summary pre and post submission PSG teleconferences are new in gdufa 3. the teleconference request is granted or denied within 14 calendar days from receipt of your request there are two formats a teleconference which is Audio Only or a written response only an applicant may choose which format they prefer your teleconference is

held within 30 calendar days from receipt of your request the teleconference is typically 60 Minutes in duration and the PSU teleconference can be held for both complex and non-complex drugs products an applicant should request a PSG teleconference when they have commenced or completed in Vivo be studies that are different from fda's newly published psgs which are new or revised this is a flow diagram of PSG

teleconferences and PSG meetings for your review PS3 meetings will be discussed in the next presentation and finally this is a research slide that has resources referenced in my presentation thank you so much for attending my presentation good afternoon my name is hee-san Chong I'm a lead pharmacologist in divisional bike events one office of Bio equivalence in office of generic drugs today I'll talk about the good

Factory products Facebook guidance meetings the learning objectives of my presentation are to describe the scope of an eligibility for the PSG meeting describe the communication process for meeting Grant denied decision explain the timeline and process for PSG meeting describe the communication process for the preliminary written communication I will not discuss where to submit the pre-submission and post submission PhD meeting request meeting minutes and this period

of minutes since they were already mentioned in the previous presentations I use several acronyms throughout the presentation and I have included them here for your reference including Factory commitment letter the agency agree to certain time frames and procedures for scheduling and conducting the PHD teleconference and PSG meeting the PSG Tower conference is means to provide feedback on the potential impact of new or revised PSG on

the applicant's development program the purpose of the PSG meeting is to provide a forum in which the applicant can discuss the scientific rationale for an approach other than the approach recommended in the PSG to ensure that the approach of complies with the relevant statutes and regulations the PSG meeting should be used to discuss the questions related to the proposed alternatively approach that is different from the

current PSG um the agency will not discuss the questions unrelated to the alternative view approach onto the recommendations in the current PSG here is an overview of the PSG teleconference and PSG meeting process and starting from the left side of your screen um once you have PSG teleconference and or you need to do additional work in other words there is impact from the new revised PSG

on your application then you there may be additional questions um in this regard um you have three options in approaching the agency one is to consider the PSG meeting request um another is to use the control correspondence approach where um if the question would involve only let's say one discipline um and the question is more straightforward than uh control may be more appropriate after they control

the correspondence if there are any unresolved issue and or if you have any additional questions then you still have the option to reach out to agency through the PSG meeting process it is also possible that in addition to PSG related questions or you have questions um arising from different aspects of the application for example um some scientific question or clarifying question or based on the uh

the DRL or the crl that you receive and so as applicable you you do have the option to contact the agency through different meeting types for example in the pre-submission stage you may consider the product development meeting or even the per submission stage then you might consider enhanced mid-cycle review meeting or the post crl scientific meeting here are the timeline and format of the PHD meeting

if it is granted the meeting type may be the pre-submission PSG meeting if Enda hasn't been submitted there is also post submission PS meeting if the Ender has been submitted the grand denied decision will be provided within 14 days of the receipt the meeting will be held within 120 days of receipt for the pre-submission PHD meeting for per submission stage this is within 90 days the

duration of the minimum will be 60 minutes the available meaning formats are in person face to face video conference teleconference or written response the minutes will be provided within 30 days after the PSG meeting and um that number of days mentioned on this slide referred to the calendar days now let's talk about the eligibility for the PSG meeting unlike some of the other meetings the PHD

meeting is available to both complex and non-complex products as with the PSG Tower conference you are eligible for one PSG meeting request for each new or revised PSG you should already have a hat PSG teleconference and it should have occurred in the same phase as the PSG meeting that is being requested and I'll talk about this what same phase means in the subsequent slide specific to

the post submission PSG meeting um you should not have responded to the DRL or crl if you are considering the PSG meeting let's look at what it means to be in the same phase if the psgt con was in pre-submission stage and you're requesting PhD meeting in the pre-submission stage then this is considered same phase likewise if your PhD t con occurred in post submission stage

and your meeting request uh for the your PSG meeting request is also submitted in the post submission stage then this is also considered same phase however if you or tsgt con was in the pre-submission stage but you waited until put submission to request the follow-up PSG meeting then this is not considered same phase and the agency will deny the post submission PSG meeting request in that

case let's take a look at the reasons for denying the pre-submission PSG meeting the agency intends to deny the pre-submission PSG meeting if there was no pre-submission PSG Tower conference or and that was submitted after having pre-submissioned PSG teleconference the agency may deny the pre-submission PSG meeting if the meeting request is incomplete or inquiry will be better suited for the control to correspondence or if same

or similar questions were submitted in a request for another meeting type or a control in other words you don't want to duplicate the request um in a different meeting format or other avenues of communication what about reasons for denying the post submission PSG meetings the agency intends to deny the post submission PSG meeting if there was no post submission PSG teleconference or the PSG teleconference was

held in the pre-submission stage and the end that was submitted and the applicant request post submission PSG meeting in other words PSG teleconference and PSG meeting requests are not in the same phase the agency may deny the post-submission PSG meeting if meeting request is incomplete the inquiry will be better suited for controlled correspondence or same or similar question was submitted in another meeting type or control

of Correspondence and additionally if the questions in the meeting package have been addressed during the end assessment or the applicant responded to the deficiencies in DRL or crl considering the scope of the PSG meeting it's also possible that the meeting requests be partially granted that is if the applicant includes questions not related to the alternate turbo approach then that question would be denied while the other

question that may be related to the the alternative approach then that question would be granted if the meeting request is denied then the subsequent request to schedule a pre or post submission PSG meeting will be considered a new request the meeting Grant deny notification will be provided in a written format if the meeting request is denied then the written notification will include the reason for the

denial if the meeting is granted and the agency will be providing only the written response instead of holding a meeting then will advise the applicant then written response only is forthcoming what are the things to consider in terms of when to submit the pre-submission PSG meeting request uh the meeting request should be submitted in a timely manner after the PSG tele conference and you should also

consider the time needed to develop the meeting package and when you plan to submit the um and for the Post submission or PSG meeting request you should consider the end status and the assessment cycle um as well as the time needed to develop this meeting package um and also uh you should allow us to compete our scientific evaluation of this and the submission and that is

uh refrain from requesting a post submission PSG meeting until you heard back from us on through a DRL or crl another concept to keep in mind is one meeting at a time so for example if you are waiting to hear back on Grant denied decision for another meeting or you are granted a meeting um and you know yet to have had that meeting then you should

not request a PSG meeting we also ask that you not submit the control correspondence and a PSG meeting request around the same um or time with the same or similar question if you request multiple requests containing similar or same question then we're determined which meeting or the request me most appropriate and accept that meeting and deny the rest there are other options for feedback um then

I have mentioned the controlled correspondence as well as other meeting types in earlier slide and for example there is different turn on time for various meetings and at different stages of um and the application also depending on which meeting type you request there may be impact on the golden extension for example also there are various factors and you want to figure out what works best for

you on based on the priorities for your application the guidance mentioned at the bottom of the screen has detailed information about what to include in the meeting package uh so I would you know highly encourage you to look at the guidance that said um I didn't want to put some emphasis on some of the key information for you to consider or you want to identify the

meeting time it's a free or post submission PS meeting um you want to propose the meeting format that you want um and include the PSG teleconference date um and the event ID and especially since the prerequisite to PSG meeting is the PSG teleconference in the same phase also be sure to include the scientific alternative approach to establishing by equivalence with justification rationale and the data to

support the discussion also be sure to submit the meeting package and meeting requested concurrently the PHD meeting may be rescheduled um for various reasons and which include additional information is needed from the applicant there are essential attendees who can no longer attend the scheduled meeting due to emergency or there may be um additional FDA offices they may need to participate uh in this meeting but they

cannot attend originally scheduled date it's also possible that there's a pending regulatory policy issue or that matter of fact a response to questions or the federal government is closed or opening is delayed uh due to inclement weather emergency or other reasons if the PSG meeting needs to be rescheduled or you should not submit a new meeting request the agency intends to provide the preliminary written comments

five days before the meeting and these written comments should not generate summation of new questions um if you consider that the written comments provide adequate response to some of the questions then you may leave those out in the updated agenda um and consider focusing on the meeting time on the remaining questions or any clarification you need from or for those responses and the updated meeting agenda

should be submitted uh no later than 48 hours before the meeting if you are satisfied with all the preliminary written comments then you may request to cancel the meeting I also note that the preliminary written comments are not construed as the final um unless there's an agreement between the agency and the applicant it's also possible that PSG meeting gets canceled on some of the reason for

this could be that the end or the prospective and the applicant withdraw submitting requests for one reason or other um also if the um the applicant considers that the agency provided adequate response to their questions on in the preliminary written comments for the pre-submission PSG meeting if the prospective and the applicant submit and then the PSG pre-submission PSG meeting will be canceled for the put submission

meeting if agency refused to receive the end or applicant response to the crl or DRL then the PSG meeting or post submission PSC meeting will be canceled if the PSG meeting is canceled or the subsequent piece PhD meeting request will be considered a new request let's talk about the expectation on the day of the PSG meeting the presentation is not required but if you choose to

give a presentation on be reminded that the meeting time will not be extended to include the meeting or the presentation so be judicious about how you want to use the 60 Minutes you have the discussion should focus on the clarification of the preliminary written comments and we will not address or discuss new data or questions not presented in original meaning package let's take a look at

a couple of challenging questions the first question is which of the following statements is not true a PSG teleconference should have been granted and held before PSG meeting can be requested p with each new or revised PSG the end the applicant can request one PSG meeting C both complex and non-complex products are eligible for a PSG meeting d the pre-submission PSG meeting will be held within

90 days of the meeting request take few seconds to consider your response if you chose D then you are correct the pre-submission PSG meeting will be held within 120 days of meeting requests the 90 days is for the Post submission PSG meeting foreign let's take a look at the Second Challenge question which of the following statements is not true a after pre-submission PSG teleconference pre-submission PSG

meeting may be requested if Enda has not been submitted B post submission PSG meeting should occur before responding to a possible bioequivalence deficiency identified in a discipline review letter or by equivalence deficiency identified in complete response letter c meeting agenda cannot be updated after meeting request submission D FDA will not address or discuss new data or questions not presented in original meeting package take few seconds

to consider your response if you choose C then you're correct bidding agenda can be updated after original meeting request submission that is after you receive the preliminary written response for the questions you've consider adequally addressed then you can leave those out for the actual meeting agenda but Focus the meeting discussion on those questions where if you the clarification is needed so that's a scenario where the

meeting agenda might be updated here's a summary of the PSG meeting the scope of the meeting is to discuss the questions related to the proposed alternative B approach that is different from the recommendations in the current PSG in order to have the PSG meeting you should have had a PSG teleconference in the same phase as the PSG meeting that's being requested both the complex and non-complex

products are eligible for the PSG meeting the grand denied decision will be made 14 days within 14 days of receipt the meeting will be held within 120 days of receipt if in the pre-submission phase 5 in the post submission phase then will be held within 90 days the meeting formats available for PSG meeting are in person face to face video conference teleconference or the written response

the duration of the meeting will be 60 minutes and in lieu of the PSG meeting you do have the option to submit control correspondence or request other meeting times based on the scope of question and eligibility here are some resources that you might consider or the third bullet point is for the product specific guidance meetings or between FDA and and the applicants under Godiva 3 and

this is a new guidance um undergraded for 3 and was published February of this year and I like to also uh bring your attention to the last bullet point for the controlled correspondence related to generic drug development guidance or this guidance was updated and posted December last year um I would like to thank the event organizers for inviting me to give this talk um I would

also like to recognize the gutifa 3 PSG working group who worked very hard to develop this process for the PSG meetings and also in developing this guidance um the working group involved members from the various disciplines within the office of generic drugs as well as our colleagues from the office of pharmaceutical quality oh thank you for your attention I'll be happy to answer any question you

might have during the question and answer session thank you thank you all for the great presentations we'll now move into our q a panel discussion in addition to our speakers we welcome Dr Robert Lineberger director office of research and standards in OGD Dr partha Roy director officer by equivalence and OGD Dr panaki design senior biologist office of life cycle drug products office of pharmaceutical quality and

Cedar Dr John Ibrahim associate director for Regulatory Affairs office of regulatory operations in OGD and Dave coppersmith regulatory Council division of policy Development Office of generic drug policy and OGD looks like we do have some questions coming in right now the first questions will go to Dr lay Zhang and here is the first question can an alternative approach to in Vivo be study specified in a

PSG document without any data be requested under a product development meeting for non-complex generic drugs okay thank you for the question um in this situation if it is for a non-complex product it will be under the May ground situation so FDA May ground meetings to applicants in the situation that may be um Beyond what's described in the kaduba3 commitment letter and in doing so normally we'll

consider the complex the the complexity of the issues and what's the available resource in the workload and what's the anticipated value to the end assessment process so based on this question it seems um mentioned um alternative PSG method without data it could be hypothetical then depends on what alternate method they will propose it may or may not worse thing so um if the meeting is not

granted typically FDA will recommend uh sending a control or some other appropriate Pathway to ask the question so it will be depend on the situation so FDA May Grant a pre and a product development meeting for a non-compass product it depose alternative approach to the PSG it will depend on the situation thank you thank you for responding to that question moving on to the next question

for Dr Zane it's the following if a company has not previously requested a product development meeting for a complex drug device combination product for which there is not a PSG and submits a controlled correspondence to s a specific question would FDA advise a company to request a product development meeting yeah again it will depend on the question it seems like this is a complex product and

there's no PSG they will meet the criteria for FDA will ground situation so most likely if they will run the meeting depends on what question they asked and I don't understand the question do they have a conscious or no control because typically we don't want the same question to be asked through control and the meeting request the same time so if they have a control before

with the question which is okay they can send still send a pre product development meeting for some other questions related to their product so again it depends on the situation they can submit the request and the FDA will during the grand deny stage will assess the questions and decide whether Grant the meeting or not thank you thank you for responding to that question we have one

more question for doctors saying in this round and here is the question what are parts in the meeting process that cause issues and where where is there confusion on appropriate steps to take yeah thank you for the question I will try to um answer this question based on my understanding of the question I know it's kind of General but I just want to um highlight that

under godduffa 3 and the applicants now have a variety of methods to interact with FDA including the controls through the life cycle like both pre-submission and post CIO and also scientific meetings including product developmenting pre-submission meeting now also post your scientific meeting and PSG meetings so each of these communication pathway designed to serve a specific purpose and have great potential to be valuable to the applicants

in developing to help them develop the product and also develop the quality submission to facilitate the end assessment when the application is in-house so understanding the difference between those different meetings versus controls is very important um it will be determined based on the complexity of the products whether there is a PSG developed published or not or whether whether what the specific question the applicants may have

and what the stage of the development whether it's pre-submission versus during the end that review phase or post action after they receive the CIO can all help determine which pathway so I would suggest the applicant to review fda's guidance maps and also as mentioned in my presentation FDA had developed a infographic which is a useful tool to help navigate through those various communication Pathways to determine

which meeting to select or whether you want to do controls in lieu of the meetings typically meetings are more addressed multiple questions multiple multi-disciplinary kind of questions and it will be more efficient to go through the meeting pathway controls the minimals I want I can go to Stepping focus more focused question could be do do with controls um and also depends on whether the product is

a complex product on complex product can all help make the decision so the the infographic has the first page it's a flowchart to help the applicant navigate through which meetings or which com depend on the at the end stage as well as the complexity of the product and the second page have tables designed to delineate different meetings versus when to request controls in lieu of the

meetings so I would suggest that's a very useful to to help address questions people may have um in a confusion or whether they have a confusion on which route to take what FDA observatives people like for the pre-submission meeting we do see people may not follow the redesigned feature of the pre-submission meeting by asking questions which they really should present their unique data to that da

so this part applicants should pay attention to and also when FDA denies the meeting if the meeting is not appropriate for their meeting request in general FDA I would recommend athlete forward to the applicant either you know get a better building package or maybe go to control as another pathway um and the other thing is we do as I mentioned that we do discourage applicant to

not send the same question or similar question to multiple meetings or more or control the same time as this could cause some confusion or maybe even delay some of the assessment FDA will deny duplicative requests and will only pop address questions within the proper venue um I hope that help address your question and I hope you found this webinar helpful to address any confusion you may

have in the new class 3 meeting process thank you thank you for responding to that question it's a group of questions moving on to our next panelists we've got a couple questions that came in for Karen bingston and here is the first question is it possible to record to request a pre-submission meeting for an and a re-submission following a complete response letter thank you for the

question so the short answer is no um pre-submission meetings are available for prospective applicants before they submit their application um only addition would I would want to add is that if an application is refused to receive then in that case an applicant May if they're eligible request a pre-submission meeting but otherwise only available to those in the pre-enter phase thank you thank you for responding that

question the next question for Karen bingston is the following if a pre-submission meeting is granted but we did not have a product development meeting will we still qualify for a mcrm or an em RCM thank you for the question so if you haven't had a prior product development meeting for the same that same complex product and only a pre-submission meeting it's really based on the agency's

discretion on whether a company can be eligible for a mid-cycle review meeting or an enhanced mid-cycle review meeting so if FDA does determine that you can request one it will be that information will be included in the Anda filing acknowledgment letter thank you thank you for responding to that question we've got one more question in this round for Karen bingston and here's the question can I

change an in-person P sub meeting to video conference or teleconference closer to the meeting date again thank you for the question so it is okay to change a meeting format from an in-person to a video conference if needed closer to the meeting date however a teleconference is not the appropriate format for a pre-submission meeting due to the redesign of the pre-submission meeting which is really intended

to for a presentation and sharing of screens so if if needed it would go to a video conference and not a teleconference thanks thank you for responding that group of questions moving on to our next panelists we've got a few questions that came in for Dr talbye and here is the first question for Dr bye is a pre-filled syringe a complex drug device combination product thank

you for the question so in short pre-filled syringe is a drug device combination product but it may not be necessarily eligible for a complex drug device combination product it really depends on the specifics and the complexities related to the product API or formulation um so here I like to um emphasize emphasize that it seems um people are confused about drug device combination products and the complex

products some people feel or believe drug device combination products will be eligible for complex products but in fact not all drug device combination products are complex one a drug device combination product has a device design in it and that device design may not impact the drug delivery to the site of action or absorption it is typically considered a non-complex drug device combination product so for example

some simple pre-filled syringe and needle for injectable solution where the device portion of the product does not play a key role in the dose delivery in these cases that these products are not considered a complex drug device combination products uh but on the country some peripheral syringe having a higher level of complexity um including a dual chamber syringe or Modi those pain injector those products uh

are eligible for a complex generic drug products um so here I like to share two pieces of good reference documents with you in case you have additional questions related to complex drug device combination products or in general complex products the first one is um Manual of policies and procedures 5240.10 titled with classifying approved new drug products and Drug device combination products as complex products for generic

drug development purposes and second reference is our two first three commitment letter in which the complex generic product is also defined there so please refer to these two documents for additional details if necessary thank you thank you for responding to that question we have a couple more questions for Dr Bine here's the next question is there a Time by which the post crl scientific meeting must

be requested once a crl is received sorry can you repeat the question is there a Time by which the post crl scientific meet must be requested once a crl is received thank you for the question um so in short there is no time limit for requesting a post crl scientific meeting request as long as your Anna is in the crl status and your uh your meeting

request meets the eligibility requirements you are eligible to submit the scientific meeting request so this is a different from the post URL clarification meeting request there is a specific timeline 10 days associated with the clarification t-con meeting but there is no specific timeline associated with a scientific posterl scientific meeting request thank you for responding to that question we do have one more question for Dr buying

this round and here is the question can I request both a post crl clarification teleconference and a post crl scientific meeting at the same time thank you for that question um so a quick answer is yes you may request these two meetings separately at the same time because these two meetings have different objectives and Scopes so if you feel you have questions falling into the scope

of each meeting request you may submit these two separate meeting requests to the agency thank you for responding to that question moving on to our next panelist a few questions came in from caliope cerago and here is the first question what kind of response can we expect at the PSG teleconference um add a PSG teleconference FDA will provide a pathway forward for the applicant um I

shared some outcomes in my presentation but some additional outcomes may include if FDA has recommendations where for example the PSG recommends a fasting and fed study and the applicant did a fasting study only in this case FDA will provide feedback on steps for the applicant to move forward with their application also as mentioned in my presentation if questions are better suited for submitting through the control

correspondence pathway FDA will direct the applicant to submit a control correspondence in lieu of holding the PSG teleconference FDA may also recommend the firm submit a PSG meeting if that pathway will better address their questions or if more in-depth scientific discussions are needed FDA may also provide feedback perhaps if a submission is in the early stages of review such as a pre-crl or pre-mid cycle review

in this case FDA May provide industry feedback that their application is still under review and the crl will be issuing soon another outcome may be if FDA States the new or revised PSG doesn't impact the applicant's development program and therefore future communication with FDA on this issue is not recommended thank you thank you for responding to that question got a couple more questions for Dr caliope

Sarah go and here's the first here's the next question if an applicant had a PhD teleconference meeting and the PSG was revised after the meeting can an applicant applicant request another teleconference meeting that's a great question if the PSG is revised after your first teleconference meeting was held you may request another PSG teleconference however you must meet the criteria for holding a teleconference for the new

revision thank you thank you for responding to that question got a couple more questions from Miss Sarah go and here's the next question what are some reasons for denying a post submission PSG teleconference yes post-submission PSG teleconference um where the the applicant was denied because um the applicant the AMD applicant withdraws their application um or FDA refuses to receive their amda application those would be a

couple examples thank you thank you for responding to that question I have one final question in this round from a Sarah go and here's the question when should I submit my teleconference package for a pre or post submission PSG teleconference request your uh teleconference package should be submitted to FDA so that it's received concurrently with your teleconference request keep in mind that your pre-submission teleconference package

will be submitted through the next-gen portal and your post submission teleconference package will be submitted through the Gateway thank you thank you for responding that group of questions moving on to our next panelist we've got a couple questions that came in for Dr hisan Chung and here is the first question for Dr Chung for a PSG teleconference slide 8 States a PSG teleconference can be requested

when the PSG was revised to include and in Vivo study where the PSG did not include in the Divo study previously however slide 9 states that a PSG teleconference cannot be requested in this scenario can you please describe the differences between these two scenarios thank you for that question uh this question which I came for Kelly will be about Arya answered them since it's more tied

to the review aspect of it uh so distinction to be made here is the option to demonstrate by equivalence so for example it's possible that uh the original PSG only recommended in vitro option to demonstrate by equivalence and then PSG is revised so then there is additional option in Vivo approach to demonstrate by equivalence which means in that case the applicant can choose either of the

in vitro or in Vivo option to demonstrate by covenants therefore if the uh and that applicant initiate the individual study then uh you know you're fine you don't have to go forward and asking about it do we need to conduct people study or not because the PSG is clear in saying that you have these two options to demonstrate by equivalence on the other hand if the

PSG only recommended let's say in vitro study originally and then PSG is revised so that now in addition to in vitro study um you also need to conduct in Vivo study to demonstrate by Commerce in other words you need to conduct both in vitro and individual study for overall bioquence demonstration that both studies are needed for the uh the end application so in that case since

we are following the previous PSG recommendation and now agency revised a PSG to add in Vivo study then you are eligible for the PSG teleconference and PSG meeting as appropriate um so that hopefully helps to clarify whether the distinction between the information is slide 8 and 9 for teleconference thank you thank you for responding to that question moving on to the next question for Dr Chung

here's the question are PSG teleconferences and PSG meetings available only for the original cycle thank you for that question um you remember that PSG can be revised not just starting let's say pre-submission or the original cycle of the Anda but PSG maybe revised after CR for example or subsequent CR and so the PSG tele conference and PSG meeting is not limited to the original cycle but

any subsequent PSG revision uh then you may be eligible for this process thank you thank you for responding to that question we've got a couple more questions for Dr Chung and here's the next question for post submission PSG meetings why should we wait after the PSG meeting to respond to the DRL or crl this is a very valid question um that we we our rationale for

suggesting the PSG meeting only after you listen or get our DRL or the crl is that as you know the PSG upcoming post uh PSG posting uh is available to the public and also internally we'll be aware of the upcoming PSG region for example in which case When we dropped our DRL response or the crl response we would have considered the impact from the PSG revision

on you know what may be needed for your application moving forward in addition let's say if you have to make some modification to the study design or not or whatnot um it's also possible there are elements that you want to consider or if you have to repeat certain study or consider a new study design and so it would be beneficial for you to take a look

at the DRL or the crl as you know appropriate based on the timeline to consider you know what questions you want to ask agency or to make your PSG meeting process beneficial and more meaningful for your algae program moving forward thank you thank you for responding to that question I have one more question for Dr Chung and here's the question and we have questions related to

a revised PSG as well as questions on the crl received which meeting should we pursue thank you for the question um one thing that's important to keep in mind is that PSG teleconference and PSG meetings the the scope is very narrow so it has to be tied to the PSG revision or a new PSG but if you have some additional questions um besides you know those

related to the PSG then if you submit that meeting request we likely not you know answer those questions so if you have additional questions it may be more useful for you to approach for example post crl scientific meeting if it's in the post submission stage so then you have uh you you get you know more risk proper response for each questions you have rather than only

select questions thank you thank you for responding to that question moving on to our next bonus we've got a few questions that came in from Dr Robert lionberger and here's the first question for Dr leinberger the regulations outlined under gdufa 3 and in the meetings guidance State and that the FDA May Grant a posterioral scientific if an fda's judgment the request raises issues that are best

addressed via this meeting process and cannot be adequately addressed through controlled correspondence does this language mean that the FDA will allow exceptions to the defined criteria for qualifying a post crl scientific meeting request in other words will the FDA Grant post crl scientific meetings and situations where the drug product is not a complex product and it does not include one of the four equivalency seamless Criterion

but may have a complex regulatory history or other complex and unique challenges all right so just to remind people that the commitment letter outlines the places where you can be assured that you will get your meeting granted all of the other conditions again that are outside the commitment letter depends on available resources and FDA sole discretion and you know and so with that I think you

should look at the price at the sort of prioritization again a lot of them could do for three meetings especially the post-cr scientific meetings were designed and intended for complex products and as well if a question cannot be answered through a control correspondence so we encourage you to you know use the control correspondence if it's a non-complex product your first venue is to use the control

correspondence pathway this now posts crl is now available to all products so you can get a guaranteed timeline for your control correspondence question but if there is a question where really the control correspondence meeting is not sufficient I.E there's something extremely unusual about the situation you know FDA may you know FDA has some discretion to accept a meeting request however you know I would encourage you

also to use the other things that are available especially the post crl teleconference to get clarification because in those cases you can also get advice FDA may direct you to a meeting rather than the control correspondence and that's one way you might be able to find out if it's useful but again for those situations a non-complex product that doesn't meet the commitment letter your first option

is control correspondence if the control correspondence perhaps doesn't work right then FDA may direct you toward a meeting if there's something that needs face-to-face interaction on that but again the recommended and preferred pathway in that situation is to use the new control correspondence mechanism to get input on even more complicated questions thank you Dr lionberger for responding to that question we do have a couple more

questions and here's the next question Can I submit a meeting request for a post crl scientific meeting if my questions do not belong to one of the four categories specified in the commitment letter so if you have a question on a complex product right you can always submit a control correspondence and a control correspondence should be your first option right the timeline for answering a control

correspondence is faster than answering a meeting so again you're again the first option if you're not eligible for the meeting is you know can my you know can my question be answered by control correspondence and use that and that's accessible for all of the products so we encourage you to use that again the posterior scientific meetings if you look at the four examples that are given

in the commitment letter are really all about places where it's a new you know it's really a new study design a change in direction from the previous what was submitted in the application and so if you fall you know fall into something that's like those four questions but perhaps not exactly this the situation where you're trying you know where it's a new approach to equivalence you

know then it's possible that FDA would be more likely to Grant a meeting in those cases but again the first option should be if I have a question that's about my application use the control correspondence process to get clarification before resubmission but again you know if it is if it is something that's you know that's uh that's similar in scope to those four questions I.E new

study design where interaction and discussion about the approach forward would be valuable than than you might consider submitting the meeting request and then FDA again as I said we'll evaluate it again based on resources available and you know the other time commitments that we have you know as part of the could do for three negotiations we set up these rules to balance the rules against the

resources that were provided for these particular parts of the program so that's why there's a guarantee of the meeting for certain types of questions but again other cases it's up to the discretion but I think if you you know if you're thinking about when you're more likely to be successful in submitting a meeting requests and it's when it's when a question is very similar to the

ones that it's on a complex product and it's similar to those type of those type of questions where again a new approach is needed and you want to get feedback before resubmission because fda's criteria is going to be is this going to make the review process more efficient and is this something that we couldn't answer as well in the control correspondence so if we think well

look this is a good question but we could have just answered it in the control correspondence that's probably the better option and many of your control correspondences you'll get an answer faster than even waiting for the meeting response so the control correspondence again should be the should be the first option again you know in a very specific situations where the control correspondence type approach would not

be appropriate because of the type of question that's asked those are cases where you might want to submit a meeting or if you've had some previous interaction with FDA where we might recommend your follow-up via meeting request for example if you send in a control correspondence our response to that control correspondence might be that you might consider sending in a meeting request or you might hear

that from some other interaction so there may be cases where FDA staff might direct you toward that meeting process because we believe that it would actually meet the criteria of making it more efficient it'd be better and be more appropriate than the control correspondence but again control correspondence is the first option meeting up you know for the non-complex products that fall outside of what's in the

commitment letter because you know again again that's going to be part of our decision if you ask us something we could straightfor we could easily answer in control correspondence we're just going to turn that meeting request into a control correspondence or redirect you to the control correspondence pathway thank you for responding to that question I've got a couple more questions for Dr lionberger and here's the

next question if we are in the middle of an end Vivo study that is different from the PSG recommendation do we have to wait until the we have the outcome of the study to request a PSG teleconference yeah so that you know so that's a good question and it gets to a little bit broader question about why does our guidance recommend that you use the PSG

teleconference quickly and immediately after the new PSG is posted and so that's our incentive is if you think about this and in general the it's in your interest to have that PSG teleconference as soon as possible because if you're waiting for you know the if you're waiting for the outcome of studies at the PSG teleconference it's not a scientific review so FDA staff don't have enough

time to review the data that's in your study and the results of your study so it's not really useful to try to wait for the PSG teleconference to get some results it's better to have the PSD teleconference right away discuss the study design because one of the things that can happen at the PSG teleconference is FDA staff will tell you because we know when we've changed

the guidance and we've already thought about well if someone followed our previous guidance what advice would we give them you know you'll get that advice and it may be that the study that you have underway would be appropriate and our advice to you would be when that study is complete submit your application and you get that you get that answer right away if you wait until

the study is complete you'd still get the same answer but you just get it you know how many months later and that doesn't seem like it's useful so again also if the you know a situation is more problematic or challenging right at the PSG teleconference you know FDA staff say well maybe the answer will depend on the results of your study and then we might give

you some direction on what type of analysis of that study you might want to submit with it at the PSG meeting that follows up the teleconference so again you know as we think through the situations in cases where the studies in progress it seems like it's almost always beneficial to you the applicant to have that PSP teleconference right away you know and then if there is

something that depends on the results of the study we would really redirect you to the PSG meeting and then we'd also give you some direction of what we'd be looking for in the study and you can analyze it and provide the data summaries that help make your case and discuss that point but then you can get started on that meeting submission process sooner by having the

PSG teleconference soon so I would say that in you know that in almost all cases it's in the benefit of the applicant to as soon as you become aware of this PSG change is affecting a study that I've completed or in some progress have the PSG teleconference to understand what the situation is and what your next step is and then you can be the mo but

do the most effective Next Step you might get some feedback that would say well you know if your study is in process you know we would consider looking at this aspect of the data along with something else you may get some feedback that's valuable and helpful for your follow-on or you may get you know sometimes sometimes the change in the PSG is governed by changes to

the reference product and our fundamental regulations and you know we can be very clear that you know an additional study or some other study is going to be needed because and we'll you know and we'll explain to you a little bit more why in the rationale and that also can help you think about what your next step is whether you know once you understand a little

bit more why we made the change and how it relates to your situation you can make a more informed decision about what to do next so again I I would say that in almost all cases it's in the interest of the applicant to as soon as you're aware of the PSG change having an impact on your development program to have that interaction with FDA right away

and then you can move on to the next steps because we have all the follow-on meetings or follow-up approach and we'll give you the you know Direction you know you get to that follow-up Faster by having that initial teleconference and figuring out where you are thank you Dr Lamberg I have one more question and here is the question the 60-day is not in the commitment letter

why is FDA proposing 60 days you know I think you know this Cuts back to a little bit of my previous answer but I'd also asked the people in the audience why would you wait for more than 60 days because getting this information is valuable to you and the sooner you find out and get that answer to the question the more you know the the more

informed your decision for your next step can be so it's sort of baffling to me why you would wait so again we recommend 60 days but we encourage people if they're sort of a use case or a situation where you think that more time would be appropriate and more helpful you know please send that in as a comment to the guidance so that we can consider

that but again 60 days is the recommended you know recommended time to to get you know to get this in because we think that in all of the scenarios where we think of it there's no there's no scenario where it's in your interest is the industry not to know what FDA is thinking about that revision you know so we encourage you to have that interaction with

us in a timely manner but again you know give given also that you know part of it is also the resources as well right if we you know what you know that we don't want a situation where oh I have this idea I can have a PSD teleconference sometime in the next year but again if they're a reasonable reasonable reasons why a different time frame would

be appropriate encourage applicants to suggest that in you know the comments to the you know comments to the the docket as well you know again based on the resources as well we haven't received a large you know large number of these PSG teleconferences so again you know we certainly will answer the question if you ask it at any time but we're just sort of hard for

us it's hard for us as FDA to understand the situation where you'd want to wait to have this interaction it's in your interests to you know and it's getting a brief teleconference there's not a large meeting package to prepare but again if there's some other time that's all that also meets that goal and sort of reasonable as well encouraging you know encourage you to submit that

com you know submit that comment to the guidance docket as we're considering any you know any revisions or finalizations of that guidance if there's some other perspective or scenario which you think is valuable for us to consider but you know as we're thinking through from the work group what's the situation where it's better for the applicant to wait and not know what situation they're in like

it's all this is intended to help you make better decisions going forward so you know that that's our perspective on why it's written that way but you know we know if there are alternative perspectives please share you know please share them in the comments to the doctor thank you thank you Dr lionberger for responding to those questions moving on to our next panelist we've got a

couple questions that came in for Dr partha Roy and here is the first question for Dr Roy can I just request one post crl scientific meeting and ask both scientific and clarifying questions without asking for an additional post crl clarification t-con yeah um so this is like that's a great question [Music] um so um just to think about this a little bit more in terms of

um you know why we have created the postural scientific meeting I think you know obviously with those four criteria which will make you eligible for such meeting um you know this there is a this is an opportunity to have a a little bit more discussion in the scientific approach the new approach that you are taking so you have a little bit more room in this new

meeting where you can actually get into the discussion understand fda's uh you know thinking and how it could be helpful to you to move forward with a new approach right I mean that's really the the essence of creating such a meeting so that you can have a little bit more discussion now in in this process if you have some clarifications questions that are sort of connected

with the crl um then obviously you know you can ask those questions and and I'm sure within within the context of the scientific discussion we will be able to clarify and then probably we'll be able to bundle and address your clarification questions at the same meeting uh but but in an ideal way I mean you again you need to submit each meeting request separately I mean

that's sort of the line but but you also need to realize that there are different timelines for each of these and and one would be a 90-day versus a 30 day so so if you wait for your clarification questions to be answered uh that means you need to wait uh longer to get the answers for your clarification questions if you want to get the answers bundled

within the postural scientific meeting um but also you know we realize that sometimes the clarification questions might be somehow a little bit related to the new approach that you might be taking so you know taken together you know you you know you may want to have those questions clarified within the bigger posterior scientific meeting discussions thank you thank you for responding that question we've got one

more question that came in for Dr Roy and here's the question once FDA gets to review the meeting package will the assessment team be sending information requests to seek additional information from the applicant as needed if yes what is the time frame when the applicant can expect such communication yeah that's a great question um after your meeting request is granted during meeting package assessment phase I

mean if the FDA assessment team identifies any questions for your meeting package we may send an information request to you but we want to obviously want to do it as soon as possible and typically such information requests will be sent you know within the first 45 days uh in order for assessment team to have an adequate time to review your additional question generally will be you'll

be given one week uh time to respond to the to the agency so uh you know our intent is uh to kind of limit the information request that we will be sending it to you but there may be sometimes situations where we feel the need for asking you that that extra question so that you know we can comprehensively answer um your scientific questions within the meeting

so we we may ask you certain questions um but you know we really don't want to make it a a regular practice you know you know we probably you know in a rare situations We'll be asking some information requests if needed uh but but again I mean our intent is to ask this question as soon as possible uh to so that you know we can work

on on the responses you know appropriately and comprehensively thank you thank you for responding to that question moving on to our next palest we have a few questions that came in for Dr panaki design and here's the first question for Dr Desai as per Guidance the agency recommends that the meeting request for a p sub should be submitted approximately six to eight months before submission of

the amda if PSE submission is planned for the amda should I consider a six to eight month timeline for the p-sub meeting request before the submission of the PFC for this question in general you may consider the timings of your AED submission however if the information that is going to be submitted in your P submitting package which will be affecting the pre-approval inspection then you may

consider the piece of timings before the submission of your PFC such examples may include when you are proposing to use unique analytical method or when you are proposing to use unique manufacturing technique Etc thank you I hope I answer your question thank you for responding to that question I've got a couple more questions for Dr Desai here's the next question is it okay to submit questions

for the agency in the p-sub meeting package thank you for this question um so the short answer to this question is that we would not recommend applicant to include questions to the agency the B submitting type of packages um the piece of meeting is the opportunity for you to meet with the agency and to present your unique and novel data or information to us so if

you are planning to include um that you are planning to include in your AMD submission um additionally we would encourage applicants to submit peace submitting packages in a presentation format um the presentation outline template is provided in the appendix to the formal meeting guidance thank you thank you for responding to that question have one final question for Dr design and here's the question what is the

benefit of submitting my meeting package as a draft presentation if high level information is generally acceptable so if you do not meet the criteria in the gadufa 3 for when FDA will grant a pre-submission meeting in other words you do not if you did not have a prior PDL meeting with the agency or you had a PDF meeting but your product is non-complex the draft presentation

May assist FDA in determining if the piece of meeting would likely be approved um or improved the AMD assessment efficiency that's why we encourage applicants to include the high level information in their presentation thank you thank you for responding that group of questions moving on to our next Palance we've got some questions that came up for Dr John Ibrahim and here's the first question will submitting

updated stability data after the review has commenced be considered an unsolicited Amendment and will the goal date get extended thank you very much if additional information is submitted to the Anda that's not generally a response to a deficiency or an inquiry from the FDA like updated stability data yes then that could be considered an unsolicited Amendment and that could extend the gold date thank you for

responding that question we've got a couple more questions that came from Dr Abrahim here's the next question is there a specific time frame for the Post crl scientific meeting to be submitted for example the poster on the scientific meetings need to be submitted within 10 business days after the issuance of a crl thanks again um this is similar to a question that uh Dr Bai answered

uh but to to reiterate there is no time limit for requesting a post crl scientific meeting uh or receiving a goal date um that's associated associated with that any Anda that's in CR status that's eligible um for a post crl scientific meeting that meets those eligibility requirements can submit one of those posterioral scientific meetings thank you thank you for responding to that question got a couple

more questions for Dr Abraham and here's the next question should I include the criteria noted in the commitment letter and that my NDA falls under and the meeting request thanks so much uh yeah for post crl scientific meeting it's important to include the specific criteria associated with your Handa to help us manage your meeting requests more efficiently if for reference to these specific eligibility criterias it's

under c1a of the cadufa commitment thanks thank you for responding to that question we have one final question for Dr Ibraham and here's the question do I need to specify which type of meeting I'm requesting in the meeting request package all right thanks so uh yeah for uh the specific meeting request that you submit it should be included in the heading of your cover letter what

type of meeting request uh you're submitting for uh for example for scientific meter meetings you would want to submit post crl scientific meeting requests to differentiate that from a post crl clarification meeting uh to make that a little bit more easier for us to manage when we receive it um and that's best placed in the heading of your cover letter thanks thank you for responding that

group of questions moving on to our next panelist we've got some questions that came in for Dave copper Smith and here's the first question how do you clarify the meeting minutes from the PSG teleconference if the remarks are unclear thank you for the question so an applicant that's requesting clarification of the meeting minutes issued by FDA after a PSG teleconference should contact the assigned FDA point

of contact for that teleconference and the applicant should contact that FDA point of contact within 10 calendar days of receipt of the official meeting minutes to seek that clarification thank you thank you for responding to that question I've got a few more questions that came in for Dave copper Smith and here's the next question Can I submit a request for a PSG teleconference more than 60

days after the PSG was published yes applicants can submit PSG teleconference requests more than 60 days after the PSG was published as Dr leinberger mentioned earlier we recommend that applicants submit within 60 days after the new or revised PSG was issued so that FDA can provide timely feedback to applicants the 60-day time frame was included in the draft guidance for industry product specific guidance meetings between

FDA and and applicants under godufa that was issued in February for comment if they will review the comments that we've received incorporate suggested changes when appropriate and then either issue or revise final version of that guidance that represents fda's current thinking on this topic or a revised draft for comment thank you thank you for responding to that question got a couple more questions for Dave copper

Smith here's the next question could you elaborate on when a controlled correspondence may be more appropriate as opposed to a PSG meeting thank you for the question so you can refer to the draft guidance for industry control correspondence related to generic drug development for more information on controlled correspondence but as stated in that Guidance the purpose of the controlled correspondence process is to provide a mechanism

for a direct inquiry about fda's position with respect to a particular element of generic drug development and for the agency's direct brief and timely response a PSG meeting may be more appropriate than controlled correspondence if an applicant has multiple questions or the applicant's questions involve feedback from multiple disciplines within FDA applicants may also want to consider their planned Townline for and a submission or responding to

a bio equivalence deficiency in the timeline for a response from FDA because there are different timelines for responses for a long and level two control correspondence and for holding pre-submission in post-submission PSG meetings thank you thank you for responding to that question we have one more question for Dave copper Smith and here's the question does an applicant have to have had a PSG teleconference before the

applet can request a PSG meeting yes in order to be eligible to request a PSG meeting either a pre-submission PS3 meeting or a post-submission PSG meeting an applicant must first have a PSG teleconference with FDA one thing to note is my colleagues have mentioned that you know under godufa 3 there are different meeting types that are available at applicants so if an applicant has not had

a PSG teleconference and would like to discuss an alternative by equivalence approach with FDA an applicant can consider requesting another meeting type or submitting control correspondence as appropriate so for example if an applicant receives the mid-cycle discipline review letters and has not yet had a PSG teleconference and is eligible to request an enhanced mid-cycle review meeting the applicant could consider requesting an enhancement cycle review meeting

to ask questions related to a scientific approach to address those deficiencies that were identified in the mid-cycle drls so that would be an option available to that you know applicant in that situation but as I said there are different meetings available and applicants should just consider which one you know would be best for them thank you thank you for responding to that group of questions moving

up to the beginning of our panelists we have a few more questions that came in for Dr Lee Zhang and here's the first question for a combination product which which PSG suggests the conduct of clinical endpoint study over two years since PK data can be generated for the specific API what would be the best path to have FDA fda's inputs on the use of a PK

approach yep thank you for the question so what I assume this is a complex product and if we consider the PK approach is the alternative approach to what's being proposed or amended in the PSG then that applicant will be um eligible to request a product development meeting so it requires depends on the stage if it's in the pre-submission stage they can request a product development meeting

instead of a control correspondence thank you thank you for responding that question we've got a few more questions a couple more questions for Dr Zhang and here's the next question can I change the meeting format to video conference later if the meeting was granted as the teleconference okay yeah as I mentioned in my presentation no you you cannot change the meeting format from a teleconference to

a video conference after the meeting is granted however if the meeting is granted as an in-person meeting or as a video conference it may be changed from in person to a video conference or from a video conference to a teleconference if the applicant thinks the preliminary response or settings Factory and maybe the remaining questions are clarification in nature and also as I mentioned in my presentation

earlier the application should be aware of the difference between teleconferences video conference and choose the most appropriate meeting format in the meeting request thank you thank you for responding to that question okay just a few minutes left and I'll try to get in one more question with Dr Zhang and here is the question will FDA accept a pre-a meeting for non-complex products um I think this

question has been a similar question has been addressed before so it is the May ground situation most likely because the a lot of meetings three items are designed for complex project so control maybe the first option but FDA do have the discretion to decide whether ground the meeting or not depends on the issue and also whether the meeting can enhance the efficiency of the end assessment

thank you and also where the resources available thanks well a huge thank you to our presenters and Palace for your very informative And Timely talk and also for responding to numerous questions that came in we'd like to welcome back Dr lionberger to provide some closing remarks it's my pleasure to present Dr Robert lionberger thank you Ray and on behalf of all the staff in the OGD

in in Studio's generic drug program as a whole I want to really thank the sbia staff that helped organize this wonderful webinar we want to thank all of our presenters who took the time to go through and make these presentations you know the implementation of these could do for three meetings you know behind the scenes there's a lot of work groups where people work through a

lot of the different scenarios and hopefully this meeting gives you a little bit deeper presentation than just reading the guidance and helps explain you know why things work this way what are some of the considerations what are some of the edge cases and we really appreciate the time that the presenters took to put these presentations together and also recognizing that all of these presentations each one

of these different meeting types had a work group with many many more FDA staff involved that helped you know refine this and provide comments and feedback so it's really a you know a sort of whole program effort that you're seeing channeled through these presenters here today and finally I'd like to thank all of you who participated by asking questions I think this helps us understand what's

not clear it helps us design future trainings it helps us revise guidances really just helps us build a better generic drug program so we really appreciate people who take the time to ask ask questions even difficult questions I think those are the best kind and you know so hopefully you all found this Workshop very helpful I think you know again as I mentioned before the goal

from this was try to was to try to explain with a little more depth the rules than in our commitment letter and our guidance is how the meeting processes work what we actually do at the different steps in the process give you a little insight into the edge cases help you on you know understand the you know understand the rules War understand also the thinking that

FDA went through as we were developing the guidances and the practices around these different meetings and we hope that this will have two primary outcomes one is that all of you who are listening will be able to go back to your organizations and you know use these meetings more this is something the generic industry negotiated access to these meetings so when you're eligible for these meetings

when you find yourself in the development of a complex product right before you submit the application you know use that product development meeting if you're doing anything you know different than what's in the guidances or even if there's challenges implementing the guidances we generally you know are open to product development meetings that you know deal directly on things that you found to be difficult to actually

do even if they're in our product specific guidances and you know we strongly encourage you to use the new pre-submission meeting process if you've had that product development meeting and you're doing something new to take that additional opportunity to you know you know from you get this sort of you know 60 Minute one hour meeting block to talk directly to the review team help them see

the big picture of your application help them see what's new why it's there the previous interactions that you've had you know FDA staff then can really go back and be prepared to review your application you know if there's things that are novel in the application if you share them with FDA at that pre-submission meeting our staff are more likely to be well prepared to review those

when they come in in the application and a few months later so again use these meeting processes that you negotiated you know as your application progresses through the submission when you if you find yourself in a you know crl you know if the P if you you know use the things that we're negotiating to do for three use the ability to ask control correspondences after the

crl to clarify before you resubmit if you're in one of the situations where you really have to do some new study that wasn't in your previous application and it's something you know different than our guidances or some unusual situation those novel studies that's what a meeting is best for so those are the cases you know you try to enumerate those cases in the commitment letter but

there may be other things that fit in that same Spirit of look I have to do a new study there's not a guidance that tells me how to do this new study I want to have some interaction with FDA so I do the right study to help my application get approved that's you know that's what we mean when we say help the application be successful make

the review more efficient if you do the wrong study that's wasting everyone's time so in cases where you know what study to do is ambiguous those are the cases where you might think that the product the post-crl scientific meeting is important and valuable for your development programs but again you can always again another I think under look feature of gdufa 3 is now you can ask

for any question it's a complex product it's a non-complex product you can use that control correspondence Pathway to ask the question get feedback in 68 in those cases before you resubmit the application and hopefully that will do you'll be a significant contribution to getting things right the first time and finally we hope you got from this work this meeting and webinar an idea of how to

be more effective in using the meeting processes how to make them fit together how to see all the pieces that you can do all right clarification questions fast answer here then follow up with a scientific meeting if appropriate you know think about also in the pre-development space all right work through the pre-development meetings you know maybe a stepwise approach for a very complex product you know

to make sure one part is right then come back use the control correspondence to get input on the device constituentive part of your application and then use the product the pre-submission meeting to get FDA oriented to the novel approach that you're taking into your application so just think about the the you know using these but also using them effectively and you know what types of questions

hopefully you've gotten some feedback on what types and questions will be really appropriate for the different meeting venues and so you know with that it's you know it's it's been great to participate in this in this webinar and we hope that you know you all got a lot of out of it and so I'll turn it back to Ray to how to do the closeout Logistics

so again thanks to our sbia colleagues for making this you know webinar work smoothly and well and back to you Ray