0727 Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

Product-Specific
Guidance Meetings
Between FDA and
ANDA Applicants
Under GDUFA
Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to https://www.regulations.gov. Submit written
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the
docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document, contact (CDER) David Coppersmith at 301 -7969193.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)

February 2023
Generic Drugs

Product-Specific
Guidance Meetings
Between FDA and
ANDA Applicants
Under GDUFA
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4 th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353
Email: druginfo@fda.hhs.gov
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
February 2023
Generic Drugs

Contains Nonbinding Recommendations
Draft — Not for Implementation
TABLE OF CONTENTS
I.

INTRODUCTION ...................................................................................................... 2

II.

BACKGROUND ........................................................................................................ 2

III.

MEETING TYPES..................................................................................................... 3
A. PSG Teleconferences .............................................................................................. 4
1. Pre-Submission PSG Teleconferences .................................................................... 5
2. Post-Submission PSG Teleconferences ................................................................... 6
B. Pre-Submission PSG Meetings................................................................................. 6
C. Post-Submission PSG Meetings ............................................................................... 7

IV.

GDUFA III PERFORMANCE GOALS..................................................................... 8

V.

MEETING REQUESTS............................................................................................. 9
A. PSG Teleconferences .............................................................................................. 9
B. Pre-Submission PSG Meetings................................................................................11
C. Post-Submission PSG Meetings ..............................................................................11

VI.

EVALUATING MEETING REQUESTS ................................................................ 12
A. Meeting Request Denied.........................................................................................12
B. Meeting Request Granted.......................................................................................13

VII.

RESCHEDULING AND CANCELING MEETINGS ............................................. 14
A. Rescheduling Meetings...........................................................................................14
B. Canceling Meetings................................................................................................14

VIII. MEETING PACKAGE CONTENT......................................................................... 15
A. Timing of Submission ............................................................................................16
B. Where and How Many Copies of Meeting Packages To Submit .................................16
C. Meeting Package Content.......................................................................................16
1. PSG Teleconferences..........................................................................................16
2. Pre-Submission PSG Meetings.............................................................................18
3. Post-Submission PSG Meetings............................................................................19

IX.

PRE-MEETING COMMUNICATIONS WITH APPLICANTS ............................. 20

X.

PROCEDURES FOR CONDUCT OF MEETINGS ................................................ 21
A. Introductions and Agenda......................................................................................21
B. End of Meeting Summary.......................................................................................21
C. Presentations.........................................................................................................21

XI.

DOCUMENTATION AND MEETING MINUTES................................................. 22

XII.

RESOLUTION OF DISPUTE ABOUT MEETING MINUTES .............................. 22

Contains Nonbinding Recommendations
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Product-Specific Guidance Meetings Between FDA and ANDA
Applicants Under GDUFA
Guidance for Industry1

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This draft guidance, when finalized, will represent the current thinking of the Food and Drug
Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible
for this guidance as listed on the title page.

I.

INTRODUCTION

This guidance provides recommendations to industry on product-specific guidance (PSG)
meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant
that has submitted to FDA an abbreviated new drug application (ANDA) under section 505(j) of
the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).2 Specifically, this
guidance provides information on requesting and conducting PSG meetings with FDA (PSG
teleconferences, pre-submission PSG meetings, and post-submission PSG meetings), as
contemplated in the Generic Drug User Fee Amendments (GDUFA) Reauthorization
Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III
commitment letter).3 And this guidance is intended to provide procedures that will promote
well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in
accordance with the time frames set forth in the GDUFA III commitment letter.
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidance means that something is suggested or recommended, but
not required.

1

This guidance has been prepared by the Office of Generic Drugs in the Center for Drug Evaluation and Research at
the Food and Drug Administration.
2
This guidance uses the term ANDA applicant when discussing meetings that occur after an ANDA is received, the
term prospective ANDA applicant when discussing meetings that occur before an ANDA is received, and the terms
applicant or applicants when referring to both prospective ANDA applicants and ANDA applicants.
3
The GDUFA III commitment letter is available at https://www.fda.gov/media/153631/download.

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II.

BACKGROUND

The Generic Drug User Fee Amendments of 2012 (GDUFA I)4 amended the FD&C Act to
authorize FDA to assess and collect user fees to provide the Agency with resources to help
ensure patients have access to quality, safe, and effective generic drugs. GDUFA fee resources5
bring greater predictability and timeliness to the review of generic drug applications. GDUFA
has been reauthorized every 5 years to continue FDA’s ability to assess and collect GDUFA fees
and this user fee program has been reauthorized two times since GDUFA I, most recently in the
Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023.6 As described
in the GDUFA III commitment letter applicable to this latest reauthorization, FDA has agreed to
performance goals and program enhancements regarding aspects of the generic drug assessment
program that build on previous authorizations of GDUFA. New enhancements to the program
are designed to maximize the efficiency and utility of each assessment cycle, with the intent of
reducing the number of assessment cycles for ANDAs and facilitating timely access to generic
medicines for American patients.
To receive approval for an ANDA, an applicant generally must demonstrate, among other things,
that its proposed drug product is bioequivalent to the reference listed drug (RLD). 7 As noted in
21 CFR 320.24, in vivo and/or in vitro methods can be used to establish bioequivalence (BE).
FDA recommends that applicants consult published PSGs when considering an appropriate BE
study and/or other studies for a proposed drug product. 8, 9 PSGs provide recommendations for
developing generic drug products and describe FDA’s current thinking on the evid ence needed to
demonstrate that an ANDA is therapeutically equivalent to a specific RLD product.
As described in the GDUFA III commitment letter, FDA agreed to certain time frames and
procedures for scheduling and conducting: (1) PSG teleconferences to provide feedback on the
potential impact of a new or revised PSG on the applicant’s development program ; and (2) pre-

4

Title III of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144.
User fees are available for obliga tion in accordance with appropriations acts.
6
See Division F, Title III of the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023
(Public Law 117-180).
7
See section 505(j)(2)(A)(iv) of the FD&C Act (21 U.S.C. 355(j)(2)(A)(iv)) and 21 CFR 314.94(a)(7).
8
For more information about FDA’s PSG publications and to search for the most recent version of a PSG, see the
Product-Specific Guidances for Generic Drug Development web page at https://www.fda.gov/drugs/guidancesdrugs/product-specific-guidances-generic-drug-development.
9
In addition to consulting published PSGs, FDA also recommends that applicants consult FDA’s web page on
upcoming new and revised PSGs in planning the development of their drug products and prior to submitting their
ANDAs. This information is available at https://www.fda.gov/drugs/guidances-drugs/upcoming-product-specificguidances-generic-drug-product-development. FDA may refuse to receive an ANDA if the ANDA contains one or
more BE studies that were not recommended in the PSG, without adequate justification (21 CFR 314.101(d)(3)
(stating that FDA may refuse to receive an ANDA if it is incomplete because it does not on its face contain
information required under section 505(j) of the FD&C Act); 21 CFR 314.94(a)(7)). Adequate justification should
include justification for an approach that deviates from the published guidance, including data and appropriate
references. See the guidance for industry ANDA Submissions—Refuse-to-Receive Standards (Rev. 2) (December
2016). We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web
page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
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submission PSG meetings and post-submission PSG meetings 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 complies with the relevant statutes and
regulations.10

III.

MEETING TYPES

As described in the GDUFA III commitment letter, there are three types of PSG meetings that
occur between applicants and FDA: PSG teleconferences (which includes pre-submission PSG
teleconferences and post-submission PSG teleconferences), pre-submission PSG meetings, and
post-submission PSG meetings.
PSG teleconferences provide a forum for applicants to obtain FDA’s feedback on the potential
impact of a new or revised PSG on the applicant’s development program when the applicant has
already commenced (i.e., the study protocol was signed by the study sponsor and/or the contract
research organization) or completed an in vivo BE study. A prospective ANDA applicant can
request a pre-submission PSG teleconference prior to submission of the ANDA. An ANDA
applicant can request a post-submission PSG teleconference if the ANDA has been submitted.
When FDA states in a PSG teleconference that a new or revised PSG would impact an
applicant’s development program, this statement is an indicator that the applicant has already
commenced or completed in vivo study alone is unlikely to be sufficient to demonstrate BE in
accordance with the relevant statutes and regulations.
If an applicant seeks further feedback from FDA after a PSG teleconference to ensure that any
proposed changes or additions to an applicant’s in vivo study would result in an approach that
complies with the relevant statutes and regulations, the applicant may request a pre-submission
PSG meeting or post-submission PSG meeting, as appropriate, to discuss the scientific rationale
for an approach other than the approach recommended in the PSG.
As described in the GDUFA III commitment letter, a prospective ANDA applicant is eligible to
have a pre-submission PSG meeting if it first requests and has a pre-submission PSG
teleconference with FDA. 11 The pre-submission PSG teleconference and the subsequent presubmission PSG meeting should occur before submission of the ANDA (i.e., within the presubmission phase) so that the prospective ANDA applicant obtains FDA’s feedback on an
approach other than the approach recommended in the PSG before submission of the ANDA.12
As described the GDUFA III commitment letter, an ANDA applicant is eligible to have a postsubmission PSG meeting if it first requests and has a post-submission PSG teleconference with

10

GDUFA III commitment letter at 24.
Ibid.
12
FDA intends to deny a post-submission PSG meeting request and recommend the ANDA applicant submit a
controlled correspondence if the prospective ANDA applicant had a pre-submission PSG teleconference, submitted
the ANDA, a nd then requests a post-submission PSG meeting. FDA will not simultaneously assess the adequacy of
an ANDA’s demonstration of BE and consider and respond to questions submitted in a PSG meeting package .
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FDA.13 The post-submission PSG teleconference and the subsequent post-submission PSG
meeting should occur before responding to a possible BE deficiency identified in a discipline
review letter (DRL) or a BE deficiency identified in a complete response letter (CRL). For
example, if FDA has issued a CRL, the ANDA applicant should request and attend the postsubmission PSG meeting prior to responding to the BE deficiency identified in the CRL so that
the ANDA applicant can consider FDA’s feedback in developing a response to the CRL.14, 15
As an alternative to a pre-submission PSG meeting or a post-submission PSG meeting,
applicants can consider obtaining FDA’s feedback on an approach other than the approach
recommended in the PSG through controlled correspondence or another meeting type, as
appropriate.16 FDA recommends that applicants consider the types of questions on which they
want to obtain FDA’s feedback, the status of their ANDA, and the eligibility criteria for
controlled correspondence or a particular meeting type in determining which pathway to seek
FDA’s feedback. Applicants should not submit multiple meeting requests or controlled
correspondence at or around the same time with the same or similar questions. If FDA receives
multiple meeting requests or controlled correspondence that contain the same or similar
question(s), FDA will determine which meeting to grant or controlled correspondence to answer
and may deny the other(s).
A.

PSG Teleconferences

PSG teleconferences provide an opportunity for an applicant to obtain FDA’s feedback on the
potential impact of a new or revised PSG on the applicant’s development program when the
applicant has already commenced an in vivo BE study.17 During a PSG teleconference, FDA
will provide feedback on the potential impact of the recommendations in the PSG, but FDA will
not discuss the applicant’s questions regarding an approach other than the approach
recommended in the PSG. During a PSG teleconference, FDA may, if applicable, recommend a
path for future communication with FDA, such as controlled correspondence, pre -submission
PSG meeting, post-submission PSG meeting, or other meeting type.
When FDA publishes a new or revised PSG which includes a recommendation to conduct an in
vitro BE study only and an applicant has already commenced or completed an in vivo BE study,

13

GDUFA III commitment letter at 24.
If the ANDA applicant responds to the BE deficiency identified in a CRL and then requests the post-submission
PSG meeting, FDA intends to deny the post-submission meeting request and recommend the ANDA applicant
submit a controlled correspondence because FDA will not simultaneously assess the adequacy of an ANDA’s
demonstration of BE and consider and respond to questions submitted in a PSG meeting package.
15
We note that, in some instances, due to either timing of the PSG meeting (i.e., after FDA issues a CRL) and/or the
type of information necessary to establish BE using an alternative approach involving an ANDA applicant’s already
commenced or completed in vivo BE study, it may not be possible to address and provide all the necessary BE
information within the same assessment cycle.
16
For more information on controlled correspondence, see the guidance for industry Controlled Correspondence
Related to Generic Drug Development (December 2020). For more information on other meeting types, see the
guidance for industry Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
(October 2022).
17
GDUFA III commitment letter at 24.
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FDA generally would consider the submission of the in vivo BE study as an acceptable approach
for demonstrating BE. Therefore, applicants in such a situation in general should not request a
PSG teleconference, but FDA recommends, to ensure the ANDA submission is acceptable for
receipt and scientific review, that an applicant in such a situation 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. 18
Applicants should submit a request for a PSG teleconference within 60 days after publication of
the new or revised PSG so that FDA can provide timely feedback to applicants. 19 Applicants can
request a PSG teleconference more than 60 days after publication of the new or revised PSG,
however, the 30-day time frame for conducting PSG teleconferences20 (discussed in section IV
of this guidance) is only applicable for complete packages submitted within 60 days after
publication of the PSG and otherwise meet the criteria set forth in section V of this guidance.
1.

Pre-Submission PSG Teleconferences

A prospective ANDA applicant can request a pre-submission PSG teleconference when FDA
publishes a new or revised PSG that introduces or revises a recommendation related to an in vivo
BE study, the ANDA has not been submitted, and the prospective ANDA applicant has already
commenced an in vivo BE study as of the published date for the new or revised PSG (i.e., the
study protocol was signed by the study sponsor and/or the contract research organization before
the PSG publication date).21 With the pre-submission PSG teleconference request, a prospective
ANDA applicant should submit the title page, protocol summary, and the signature page of the
relevant in vivo BE study protocol signed and dated by the study sponsor and/or the contract
research organization (see section V.A for additional information on the contents for the meeting
request).22
After a pre-submission PSG teleconference has been held, a prospective ANDA applicant can
request a pre-submission PSG meeting (if the ANDA has not been submitted), utilize the
controlled correspondence process, or request another meeting type, as appropriate, to seek
further feedback from FDA regarding an alternative BE approach to the recommendations in the
PSG.23, 24

18

See footnote 9.
FDA issues a notice in the Federal Register announcing the availability of new and revised PSGs posted on the
product-specific web page (available at https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm). These notices
are also available under docket number FDA-2007-D-0369, which can be accessed at
https://www.regulations.gov/docket/FDA-2007-D-0369. FDA considers the publication date of a PSG to be the day
that the PSG is posted on the product-specific web page, which is stated on the product-specific web page and is
generally the business day before the notice announcing the PSG’s availability publishes in the Federal Register.
20
GDUFA III commitment letter at 24.
21
Ibid.
22
Ibid.
23
Ibid.
24
See footnote 16.
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2.

Post-Submission PSG Teleconferences

An ANDA applicant can request a post-submission PSG teleconference when FDA publishes a
new or revised PSG that introduces or revises a recommendation related to an in vivo BE study,
the ANDA has been submitted, and an applicant has already commenced or completed an in vivo
BE study (i.e., the study protocol has been signed by the study sponsor and/or the contract
research organization before the PSG publication date).25
FDA also intends to offer the opportunity for a post-submission PSG teleconference in the
following two situations, which are not described in the GDUFA III commitment letter:
•

An ANDA applicant can request a post-submission PSG teleconference 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 vivo BE study. 26

•

An ANDA applicant can request a post-submission PSG teleconference when FDA
publishes a revised PSG which includes a recommendation to conduct an in vivo BE
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
either that were recommended by FDA in the previous PSG or that the ANDA applicant
decided to pursue after a prior product development meeting. 27

After a post-submission PSG teleconference has been held, an ANDA applicant can request a
post-submission PSG meeting (discussed in more detail below), utilize the controlled
correspondence process, or request another meeting type, as appropriate, to seek further feedback
from FDA regarding an alternative BE approach to the recommendations in the PSG.28
B.

Pre-Submission PSG Meetings

After a pre-submission PSG teleconference has been held and if the ANDA has not been
submitted, the prospective ANDA applicant can request a pre-submission PSG meeting. The
purpose of the pre-submission PSG meeting is to provide a forum in which the prospective
ANDA applicant can discuss the scientific rationale for an approach other than the approach
recommended in the PSG to ensure that the approach complies with the relevant statutes and
regulations.29 During a pre-submission PSG meeting, FDA will discuss the prospective ANDA
applicant’s questions related to their proposed alternative BE approach which differs from the

25

GDUFA III commitment letter at 24.
FDA offers the ability to request a PSG teleconference to applicants under this scenario even though such
applicants may not meet all the criteria in the GDUFA III commitment letter. This offer is thus made at FDA’s
discretion.
27
Ibid. This offer for the ability to request a post-submission PSG teleconference does not include when a PSG is
revised to include an in vivo BE study as an additional option to the in vitro BE study that was recommended in the
previous PSG and the ANDA applicant followed the recommendations in the previous PSG.
28
GDUFA III commitment letter at 24. See also footnote 16.
29
GDUFA III commitment letter at 24.
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recommendations in the current PSG. FDA will not discuss questions unrelated to the alternative
BE approach to the recommendations in the current PSG.
Prospective ANDA applicants should request a pre-submission PSG meeting in a timely manner
after the pre-submission PSG teleconference, considering the time needed to develop the meeting
package for a pre-submission PSG meeting with FDA, and before submitting the ANDA.
Prospective ANDA applicants can request a pre-submission PSG meeting regardless of whether
they have had a product development meeting.30
As an alternative to requesting a pre-submission PSG meeting after a pre-submission PSG
teleconference, prospective ANDA applicants can consider submitting controlled
correspondence or requesting another meeting type, such as a product development meeting, as
appropriate, to seek feedback from FDA. 31
C.

Post-Submission PSG Meetings

After a post-submission PSG teleconference has been held, the ANDA applicant can request a
post-submission PSG meeting.32 The purpose of the post-submission PSG meeting is to provide
a forum in which ANDA applicants can discuss the scientific rationale for an approach other
than the approach recommended in the PSG to ensure that the approach complies with the
relevant statutes and regulations. 33 During a post-submission PSG meeting, FDA will discuss
the ANDA applicant’s questions related to their proposed alternative BE approach which differs
from the recommendations in the current PSG. FDA will not discuss questions unrelated to the
proposed alternative BE approach to the recommendations in the current PSG.
FDA recommends that an ANDA applicant consider the status of the ANDA and its assessment
cycle as well as the time needed to develop the meeting package in determining when to submit a
request for a post-submission PSG meeting. For example, FDA recommends that an ANDA
applicant refrain from requesting the post-submission PSG meeting during the assessment cycle
until after FDA has issued a DRL or a CRL to allow FDA to complete its scientific evaluation of
the ANDA applicant’s submitted evidence of BE.34 Between assessment cycles (e.g., FDA
previously issued a CRL to the ANDA applicant and the post-submission PSG teleconference
was subsequently held), FDA recommends that the ANDA applicant request the post-submission
PSG meeting once the ANDA applicant has developed the meeting package . If an ANDA
applicant intends to request a post-submission PSG meeting, the ANDA applicant should request

30

Ibid at 25.
See footnote 16.
32
ANDA a pplicants can request a post-submission PSG meeting regardless of whether they have had a product
development or a post-CRL scientific meeting (GDUFA III commitment letter at 25).
33
GDUFA III commitment letter at 24.
34
FDA will not simultaneously assess the adequacy of an ANDA’s demonstration of BE and consider and respond
to questions submitted in a PSG meeting package.
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and attend the post-submission PSG meeting prior to responding to the possible BE deficiency
identified in a DRL or the BE deficiency identified in the CRL.35
During the assessment cycle, as an alternative to a post-submission PSG meeting, ANDA
applicants can consider submitting controlled correspondence or requesting another meeting
type, such as an enhanced mid-cycle review meeting, as appropriate, to seek feedback from FDA
after a post-submission PSG teleconference.36 After a CRL, as an alternative to a postsubmission meeting, ANDA applicants can consider submitting controlled correspondence or
requesting another meeting type, such as a post-CRL scientific meeting, as appropriate, to seek
feedback from FDA. 37

IV.

GDUFA III PERFORMANCE GOALS

As reflected in the GDUFA III commitment letter, FDA committed to certain goals and
procedures for scheduling and conducting PSG teleconferences, pre-submission PSG meetings,
and post-submission PSG meetings for ANDAs. 38, 39 Applicants can request PSG
teleconferences for PSGs published on or after October 1, 2022.40 The goals described below
only apply to requests submitted on or after October 1, 2022, and subject to the criteria described
in this guidance.
FDA agreed to hold a PSG teleconference within 30 days after the receipt of the meeting request
if the request is granted. 41 This goal only applies to PSG teleconference requests submitted
within 60 days after the PSG publication.42
For pre-submission PSG meetings, FDA agreed to grant or deny the meeting request within 14
days after FDA has received the request.43 If granted, FDA agreed to hold the pre-submission
PSG meeting within 120 days after FDA received the request.44

35

See footnote 14. ANDA a pplicants may respond to other possible non-BE related deficiencies that may be
included in a DRL. Once an applicant responds to a possible BE deficiency identified in a DRL or a BE deficiency
identified in a CRL involving the new or revised PSG, FDA intends to deny or cancel the post-submission PSG
meeting.
36
See footnote 16.
37
See footnote 16.
38
GDUFA III commitment letter at 24-25.
39
Consistent with FDA’s other user fee programs, FDA will calculate the goal date from the day after a submission
(GDUFA III commitment letter at 4). Also refer to FDA’s guidance for industry Providing Regulatory Submissions
in Electronic Format—Receipt Dates (February 2014) for information on how FDA calculates receipt dates for
regulatory submissions in electronic format. As described in that guidance, requests will be received by the Agency
Monday through Friday from 12:00 a.m. to 11:59 p.m., Eastern Standard Time/Eastern Daylight Time, excluding
Federal holidays and days when the FDA office that will review the request is closed.
40
FDA in its discretion may grant PSG teleconference requests for PSGs published prior to October 1, 2022, that are
submitted within 60 days after the PSG publication.
41
GDUFA III commitment letter at 24.
42
See footnote 19.
43
GDUFA III commitment letter at 24.
44
Ibid.

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For post-submission PSG meetings, FDA agreed to grant or deny the meeting request within 14
days after FDA has received the request. 45 If granted, FDA agreed to hold the post-submission
PSG meeting within 90 days after FDA received the request. 46

V.

MEETING REQUESTS

A request for a PSG teleconference, pre-submission PSG meeting, and post-submission PSG
meeting should be submitted electronically, as explained below in this section.
Requests for a pre-submission PSG meeting can be submitted after the prospective ANDA
applicant had a pre-submission PSG teleconference and if the ANDA has not been submitted.
The pre-submission PSG meeting request should clearly indicate that the prospective ANDA
applicant had a pre-submission PSG teleconference with FDA.
Requests for a post-submission PSG meeting can be submitted after the ANDA applicant had a
post-submission PSG teleconference. The post-submission PSG meeting request should clearly
indicate that the ANDA applicant had a post-submission PSG teleconference with FDA.
If FDA determines that the meeting request does not contain the information specified in this
section, the request will not be considered to be submitted for purposes of GDUFA III
performance goals.
An applicant should not request a PSG teleconference, pre-submission PSG meeting, or postsubmission PSG meeting if the applicant has requested or has been granted but not yet had
another meeting with FDA, such as a pre-submission meeting, an enhanced mid-cycle review
meeting, or a post-CRL scientific meeting. FDA also recommends that applicants not submit a
controlled correspondence and a request for a pre-submission PSG meeting or a post-submission
PSG meeting at or around the same time with the same or similar questions. If FDA receives
multiple requests that contain the same or similar question(s), FDA intends to determine which
request to grant and may deny the other(s).
A.

PSG Teleconferences

A prospective ANDA applicant should submit a request for a pre-submission PSG teleconference
electronically through the CDER Direct NextGen Collaboration Portal.47 An ANDA applicant
should submit a request for a post-submission PSG teleconference electronically through the
Enterprise Submission Gateway. The cover page should identify the submission as a “PSG
Teleconference Request.”

45

Ibid.
Ibid.
47
The CDER Direct NextGen Collaboration Portal may be accessed a t https://edm.fda.gov.
46

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A request for a PSG teleconference meeting should include the following information:
(1) Pre-assigned ANDA number48 or ANDA number.
(2) Meeting type being requested (i.e., PSG Teleconference).
(3) Month and year the current PSG was published.
(4) A summary of how the applicant’s BE study(ies) differ from the study(ies)
recommended in the PSG.
(5) Signature page of the relevant in vivo BE study protocol signed by the study sponsor
and/or contract research organization, if applicable. 49
(6) RLD and its application number.
(7) Established Name.
(8) Proposed indication(s).
(9) Dosage form, route of administration, and strength(s).
(10) A statement indicating whether the submission is being made by the applicant or by a
U.S. agent on behalf of the applicant.
(11) Contact person for the meeting (i.e., the person submitting the request), with their title
and affiliation, secure email address, 50 and phone number. This is the person with whom
FDA will communicate about the meeting.
(12) The meeting package (see section VIII of this guidance), which should be received at the
time of the meeting request.

See information regarding requesting a pre-assigned application number on FDA’s web page at
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/uc
m114027.htm.
49
See section III.A.2 of this guidance for scenarios where an in vivo BE study was not conducted.
50
Secure email between CDER and applicants is useful for informal communications when confidential information
(e.g., trade secrets or patient information) may be included in the message. Secure email should not be used for
formal regulatory submissions. For more information on establishing a secure email link with CDER, contact
SecureEmail@fda.hhs.gov.
48

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B.

Pre-Submission PSG Meetings

A prospective ANDA applicant should submit a request for a pre-submission PSG meeting
electronically through the CDER Direct NextGen Collaboration Portal. 51 The cover page should
identify the submission as a “Pre-Submission PSG Meeting.”
A request for a pre-submission PSG meeting should include the following information:
(1) Pre-assigned ANDA number.
(2) Meeting type being requested (i.e., pre-submission PSG meeting).
(3) RLD and application number.
(4) Established Name.
(5) Proposed indication(s).
(6) Dosage form, route of administration, and strength(s).
(7) Date pre-submission PSG teleconference was held and event ID.
(8) A statement indicating whether the submission is being made by the prospective ANDA
applicant or by a U.S. agent on behalf of the prospective ANDA applicant.
(9) Contact person for the meeting (i.e., the person submitting the request), with their title
and affiliation, secure email address, 52 and phone number. This is the person with whom
FDA will communicate about the meeting.
(10) The meeting package (see section VIII of this guidance), which should be received at the
time of the meeting request.
C.

Post-Submission PSG Meetings

An ANDA applicant should submit a request for a post-submission PSG meeting electronically
through the Enterprise Submission Gateway. The cover page should identify the submission as a
“Post-Submission PSG Meeting.”
A request for a post-submission PSG meeting should include the following information:
(1) ANDA number.

51
52

See footnote 47.
See footnote 50.

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(2) Meeting type being requested (i.e., post-submission PSG meeting).
(3) RLD and application number.
(4) Established Name.
(5) Proposed indication(s).
(6) Dosage form, route of administration, and strength(s).
(7) Date post-submission PSG teleconference was held and event ID
(8) Title and study number of the study impacted by the recommendations in the PSG.
(9) A statement indicating whether the submission is being made by the ANDA applicant or
by a U.S. agent on behalf of the ANDA applicant.
(10) Contact person for the meeting (i.e., the person submitting the request), with their title
and affiliation, secure email address, 53 and phone number. This is the person with whom
FDA will communicate about the meeting.
(11) The meeting package (see section VIII of this guidance), which should be received at the
time of the meeting request.

VI.

EVALUATING MEETING REQUESTS

FDA will determine whether to grant a PSG teleconference, pre-submission PSG meeting, or
post-submission PSG meeting, and a response will be provided to the applicant by granting or
denying the meeting request pursuant to the performance goals stated in the GDUFA III
commitment letter (see section IV of this guidance) and as described below. Although applicants
can request a particular meeting type and format, FDA evaluates each meeting request and
determines whether the request should be granted, the final meeting type, and the appropriate
format.
A.

Meeting Request Denied

If a meeting request is denied, written notification to the applicant will include an explanation of
the reason for the denial.
Denials of meeting requests submitted in conformity with the GDUFA III performance goals will
be based on a substantive reason. For example:

53

See footnote 50.

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•

FDA may deny a PSG teleconference request if the applicant’s in vivo BE study started
after the PSG was published or the request is incomplete (e.g., does not include the
signature page of the relevant in vivo study protocol signed by the study sponsor and/or
the contract research organization).

•

FDA intends to deny a pre-submission PSG meeting request if the prospective ANDA
applicant did not have a pre-submission PSG teleconference or if the applicant submitted
the ANDA after the pre-submission PSG teleconference. In addition, FDA may deny the
request if the request is incomplete, FDA determines that the inquiry would be
appropriately addressed through a controlled correspondence, or the prospective ANDA
applicant submitted the same or similar questions in a request for another meeting type or
in controlled correspondence.54

•

FDA intends to deny a post-submission PSG meeting request if the ANDA applicant did
not have a post-submission PSG teleconference or if the ANDA applicant had a presubmission PSG teleconference and then submitted the ANDA. In addition, FDA may
deny the request if the request is incomplete, FDA determines the inquiry would be
appropriately addressed through a controlled correspondence, FDA determines that the
questions in the meeting package have been addressed during the ANDA assessment, the
ANDA applicant responded to the possible BE deficiency identified in a DRL or BE
deficiency identified in a CRL, or the ANDA applicant submitted the same or similar
questions in a request for another meeting type or in controlled correspondence.

FDA may grant a pre-submission PSG meeting request or post-submission PSG meeting request
after a controlled correspondence response was issued if FDA determines that any issue(s)
remain unresolved or would be more appropriately resolved in a pre-submission PSG meeting or
post-submission PSG meeting.55
If a meeting request is denied, a subsequent request to schedule a PSG teleconference, presubmission PSG meeting, or post-submission PSG meeting will be considered as a new request
(i.e., a request that is assigned a new set of time frames as described in section IV of this
guidance, GDUFA III Performance Goals).
B.

Meeting Request Granted

If a request for a meeting is granted, FDA will provide written notification to the applicant of the
decision. FDA may indicate that the request is granted in part for the questions that are
appropriate for the meeting type requested and denied in part for the questions that are not
appropriate for the meeting type requested. If FDA will be providing written responses only
instead of holding a meeting or teleconference, FDA will advise the applicant that a written
response only is forthcoming. If FDA plans to hold a meeting or teleconference, FDA will
schedule the meeting or teleconference by determining the date, time, length, format, and

54
55

GDUFA III commitment letter at 25.
Ibid.

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expected FDA participants. The scheduling information will be forwarded to the applicant either
with the notification granting the meeting or teleconference or as soon as possible following
notification that the request has been granted, and the meeting or teleconference will be
scheduled within the GDUFA III performance goals (see section IV of this guidance).

VII.

RESCHEDULING AND CANCELING MEETINGS
A.

Rescheduling Meetings

Occasionally, circumstances may arise that necessitate the rescheduling of a meeting. If a
meeting needs to be rescheduled, FDA will work to reschedule it as soon as possible after the
original date. A new meeting request should not be submitted. Applicants and FDA should take
reasonable steps to avoid rescheduling meetings. For example, if an attendee becomes
unavailable, a substitute can be identified, or comments on the topic that the attendee would have
addressed can be forwarded to the applicant following the meeting. It will be at FDA’s
discretion whether the meeting should be rescheduled depending on the specific circumstances.
A meeting may be rescheduled by FDA if, for example:
(1) The assessment team determines that additional information is needed from the applicant
to address the applicant’s questions.
(2) Essential attendees are no longer available for the scheduled date and time because of an
emergency.
(3) Attendance by additional FDA offices not originally anticipated or requested by the
applicant is critical and the offices’ availability precludes holding the meeting on the
original date.
(4) There is a regulatory policy issue that is yet to be resolved that may affect the response
to the applicant’s questions.
(5) The Federal Government is closed or opening is delayed due to inclement weather,
emergency, or other reason.
B.

Canceling Meetings

Occasionally, circumstances may arise that necessitate the canceling of a meeting. If a meeting
is canceled, a subsequent request to schedule a meeting will be considered a new request.
Applicants and FDA should take reasonable steps to avoid canceling meetings (unless the
meeting is no longer necessary). It will be at FDA’s discretion whether the meeting should be
canceled depending on the specific circumstances.
A pre-submission PSG teleconference may be canceled if, for example:

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(1) The prospective ANDA applicant withdraws the request, or
(2) The prospective ANDA applicant submits the ANDA
A post-submission PSG teleconference may be canceled if, for example:
(1) The ANDA applicant withdraws the request, or
(2) FDA refuses to receive the ANDA
A pre-submission PSG meeting may be canceled if, for example:
(1) The prospective ANDA applicant withdraws the request
(2) The prospective ANDA applicant informs FDA that its questions have been adequately
answered by the preliminary written comments, or
(3) The prospective ANDA applicant submits the ANDA
A post-submission PSG meeting may be canceled if, for example:
(1) The ANDA applicant withdraws the request
(2) FDA refuses to receive the ANDA
(3) The ANDA applicant informs FDA that its questions have been adequately answered by
the preliminary written comments, or
(4) The ANDA applicant submits a response to the possible BE deficiency identified in a
DRL or the BE deficiency identified in the CRL
If an applicant cancels a meeting, FDA will count the performance goal as met. If FDA cancels
the meeting, the meeting request will not be counted for performance goal purposes.

VIII. MEETING PACKAGE CONTENT
The meeting package should provide information relevant to the discussion topics and enable
FDA to prepare adequately for the meeting. The meeting package should clearly indicate the
meeting type the applicant is requesting and include adequate information for FDA to assess the
potential utility of the meeting and to identify the appropriate staff that should attend the
meeting.

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A.

Timing of Submission

The meeting package for a PSG teleconference, pre-submission PSG meeting, or postsubmission PSG meeting should be submitted to FDA so that it is received concurrently with the
meeting request.
B.

Where and How Many Copies of Meeting Packages To Submit

A prospective ANDA applicant should submit the meeting package for a pre-submission PSG
teleconference or for a pre-submission PSG meeting electronically to the CDER Direct NextGen
Collaboration Portal at the same time as the meeting request.
An ANDA applicant should submit the meeting package for a post-submission PSG
teleconference or for a post-submission PSG meeting electronically via the Enterprise
Submission Gateway at the same time as the meeting request.
It is not necessary to submit any paper copies of the meeting package.
C.

Meeting Package Content

The meeting package should provide information relevant to the product, development stage, and
meeting type requested, in addition to any supplementary information needed to help FDA
develop responses to issues raised by applicant. The meeting package should contain sufficient
detail to meet the intended meeting objectives.
To facilitate FDA review, the meeting package content should be organized according to the
proposed agenda. The meeting package should be a sequentially paginated document (individual
sections can be numbered separately, so long as there is an overall pagination covering the whole
submission) with a table of contents, appropriate indices, appendices, cross-references, and tabs
differentiating sections.
1.

PSG Teleconferences

A meeting package for a PSG teleconference generally should include the following information:
(1) Pre-assigned ANDA number or ANDA number.
(2) Month and year the current PSG was published.
(3) Signature page of the relevant in vivo BE study protocol signed by the study sponsor
and/or contract research organization, if applicable. 56
(4) RLD and application number.

56

See section III.A.2 of this guidance for scenarios where an in vivo BE study was not conducted.

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(5) Established name.
(6) Dosage form, route of administration, strength(s), and dosing regimen (frequency and
duration).
(7) A background section that includes the following:
•

A brief history of the development program.

•

The status of product development.

•

A brief statement of the purpose and objectives of the teleconference, including a
brief background of the issues underlying the agenda, a description of how the
applicant’s study differs from the recommendations in the PSG, and if applicable, a
statement indicating that the applicant’s in vivo study is impacted by the new or
revised PSG.

•

Summary of prior correspondence, meeting requests, and meetings with FDA
regarding the specific drug product that the teleconference request is regarding.

(8) The title page, protocol summary, and the signature page of the relevant in vivo study
protocol signed by the study sponsor and/or the contract research organization, if
applicable.
(9) The requested format57—teleconference 58 or written response only.59 For requested
teleconferences, the request package should also include the following information:
•

A proposed agenda outlining how the 60-minute time allotted for the PSG
teleconference should be apportioned to each agenda item.

•

Suggested dates and times (e.g., morning or afternoon) for the teleconference that are
within the time frame of the meeting type being requested (see section IV). Nonavailable dates and times should also be included.

57

For applicants that meet the criteria in the GDUFA III commitment letter for a PSG teleconference, FDA will
generally grant the applicant’s requested format. If FDA provides the opportunity for a PSG teleconference to an
applicant that does not meet the criteria in the GDUFA III commitment letter, FDA has the discretion to provide a
written response only or direct the applicant to submit controlled correspondence instead of holding a
teleconference.
58
Teleconference means a verbal communication by telephone, and not a written response, unless otherwise agreed
to by the applicant. GDUFA III commitment letter at 48.
59
Written response only are responses sent in lieu of a teleconference. If an applicant requests or otherwise agrees
to written response only, the written responses only count toward meeting the GDUFA goal.

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•

A list of all individuals, with their titles and affiliations, who will attend the requested
meeting from the applicant’s organization, including consultants and interpreters. 60
2.

Pre-Submission PSG Meetings

A meeting package for a pre-submission PSG meeting generally should include the following
information:
(1) Pre-assigned ANDA number.
(2) Month and year the current PSG was published.
(3) In vivo BE study protocol signature date, if applicable.
(4) Title and study number of the study impacted by the recommendations in the PSG.
(5) RLD and application number.
(6) Established Name.
(7) Dosage form, route of administration, strength(s), and dosing regimen (frequency and
duration).
(8) A background section that includes the following:
•
•
•

A brief history of the development program.
The status of product development, including status of the in vivo study.
A brief summary of the PSG teleconference discussion.

(9) A brief statement of the purpose and objectives of the meeting. This statement should
include a brief background of the issues underlying the agenda and a description of how
the applicant’s study differs from the recommendations in the PSG.
(10) The specific alternative approach to establishing BE, with justification, rationale, and
data to support discussion.

60

The applicant should notify their point of contact (POC) immediately if the list of meeting participants from the
applicant’s organization and consultants changes. In this situation, FDA may reschedule the meeting if the revised
list of meeting participants requires additional FDA personnel. In the event this meeting is ultimately rescheduled
outside the 30-day window, FDA will consider the GDUFA III goal of conducting the teleconference within 30 days
after the receipt of the teleconference request as met.

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(11) The requested format—face-to-face,61 videoconference, 62 teleconference, or written
response only. For requested formats other than written response only, the request
package should also include the following information:
•

A proposed agenda outlining how the 60-minute time allotted for the pre-submission
PSG meeting should be apportioned to each proposed question.

•

Suggested dates and times (e.g., morning or afternoon) for the meeting that are within
the time frame of the meeting type being requested (see section IV). Non-available
dates and times should also be included.

•

A list of all individuals, with their titles and affiliations, who will attend the requested
meeting from the applicant’s organization, including consultants and interpreters. 63
3.

Post-Submission PSG Meetings

A meeting package for a post-submission PSG meeting generally should include the following
information:
(1) ANDA number.
(2) Month and year the current PSG was published.
(3) In vivo BE study protocol signature date, if applicable.
(4) RLD and application number.
(5) Established Name.
(6) Dosage form, route of administration, strength(s), and dosing regimen (frequency and
duration).
(7) A background section that includes the following:
•

A brief history of the development program.

•

The status of product development.

61

Face-to-face meetings are those in which the majority of attendees participate in person at the FDA.
Videoconferences are meetings in which the attendees participate from various remote locations via a video
connection.
63
The prospective ANDA applicant should notify their POC immediately if the list of meeting participants from the
prospective ANDA applicant’s organization and consultants changes. In this situation, FDA may reschedule the
meeting if the revised list of meeting participants requires additional FDA personnel. In the event this meeting is
ultimately rescheduled outside the 120-day window, FDA will consider the GDUFA III goal of conducting the
meeting within 120 days after the receipt of the meeting request as met.
62

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•

A description of BE deficiencies, if any, received in previous assessment cycles.

•

A brief summary of the PSG teleconference discussion.

(1) A brief statement of the purpose and objectives of the meeting. This statement should
include a brief background of the issues underlying the agenda and a description of how
the applicant’s study differs from the recommendations in the PSG.
(2) The specific alternative approach to establishing BE, with justification, rationale, and/or
data to support discussion.
(3) The proposed format64—face-to-face, videoconference, teleconference, or written
response only. For requested formats other than written response only, the request
package should also include the following information:

IX.

•

A proposed agenda outlining how the 60-minute time allotted for the post-submission
PSG meeting should be apportioned to each proposed question.

•

Suggested dates and times (e.g., morning or afternoon) for the meeting that are within
the time frame of the meeting type being requested (see section IV). Non-available
dates and times should also be included.

•

A list of all individuals, with their titles and affiliations, who will attend the requested
meeting from the applicant’s organization, including consultants and interpreters. 65

PRE-MEETING COMMUNICATIONS WITH APPLICANTS

In general, FDA will not provide preliminary written comments in advance of a PSG
teleconference.
For pre-submission PSG meetings and post-submission PSG meetings, if FDA is not providing a
written response only to the applicant, FDA intends to provide preliminary written comments to
the applicant’s point of contact 5 calendar days before the meeting or teleconference.

64

For ANDA applicants that meet the criteria in the GDUFA III commitment letter for a post-submission PSG
meeting, FDA will generally grant the ANDA applicants’ requested format. If FDA in its discretion provides the
opportunity for a post-submission PSG meeting that does not meet the criteria in the GDUFA III commitment letter,
FDA has the discretion to select the format and may provide a teleconference or written response only instead of a
meeting.
65
The ANDA applicant should notify their POC immediately if the list of meeting participants from the ANDA
applicant’s organization and consultants changes. In this situation, FDA may reschedule the meeting if the revised
list of meeting participants requires additional FDA personnel. In the event this meeting is ultimately rescheduled
outside the 90-day window, FDA will consider the GDUFA III goal of conducting the meeting within 90 days after
the receipt of the meeting request as met.

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Communications before the meeting between applicants and FDA, including preliminary written
comments, can serve as a foundation for discussion or as the final meeting responses if the
meeting is canceled. Nevertheless, preliminary written comments should not be construed as
final unless there is agreement between the applicant and FDA that additional discussion is not
necessary for any question (i.e., when the meeting is canceled because the applicant is satisfied
with FDA’s preliminary written comments), or the applicant and FDA agree a particular question
is considered resolved, allowing extra time for discussion of other questions during the meeting.
After receiving the preliminary written comments, the applicant should provide an updated
agenda with its list of questions for discussion in order of priority, no later than 48 hours before
the scheduled meeting. Preliminary written comments communicated by FDA should not
generate the submission of new questions, and new questions will not be entertained a t the
meeting.

X.

PROCEDURES FOR CONDUCT OF MEETINGS
A.

Introductions and Agenda

PSG teleconferences will be chaired by an FDA staff member, will include a division director or
designee from the generic drug program, and will begin with introductions and a statement of the
agenda. In general, the meeting participants will discuss the potential impact of the new or
revised PSG on the applicant’s development program.
Pre-submission PSG meetings and post-submission PSG meetings will be chaired by an FDA
staff member, will include a division director or designee from the generic drug program, and
will begin with introductions and a statement of the agenda. In general, the meeting participants
will discuss questions posed and the data provided by the applicant.
B.

End of Meeting Summary

Before the end of the meeting, FDA attendees and the applicant attendees should summarize the
important discussion points, agreements, clarifications, and action items. Generally, the
applicant will be asked to present the summary to ensure that there is mutual understanding of
the meeting outcomes and action items. FDA staff can add or further clarify any important
points not covered in the summary, and these items can be added to th e meeting minutes. The
summary can be done at the end of the meeting or after discussion of each question.
C.

Presentations

Presentations by applicants are not generally needed because the information necessary for
review and discussion should be part of the meeting package. If an applicant plans to make a
presentation, the presentation should be discussed ahead of time with the FDA point of contact to
ensure that FDA has the presentation materials ahead of the meeting, if possible. All
presentations should be kept brief to maximize the time available for discussion.

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The length of the meeting will not be increased to accommodate a presentation. If a presentation
contains more than a small amount of content distinct from clarifications or explanations of
previous data or contains data that were not included in the original meeting package submitted
to FDA for review, FDA staff may not be able to provide comments on the new information.
FDA does not expect that applicant attendees of a PSG teleconference will provide any
presentations.

XI.

DOCUMENTATION AND MEETING MINUTES

Documentation of meeting outcomes (responses to the questions and outcomes of any
discussions regarding the responses), agreements, and disagreements is critical to ensuring that
this information is preserved for meeting participants and for future reference. FDA minutes are
the official record of the meeting. FDA intends to issue the official, finalized minutes to the
applicant within 30 days after the PSG teleconference, pre-submission PSG meeting, or postsubmission PSG meeting.

XII.

RESOLUTION OF DISPUTE ABOUT MEETING MINUTES

On occasion, there may be disputes regarding the accuracy and sufficiency of the minutes of a
PSG teleconference, pre-submission PSG meeting, or post-submission PSG meeting. An
applicant requesting additional clarification of the meeting minutes issued by FDA should
contact the assigned FDA point of contact. FDA recommends that the applicant submit its
concerns about the meeting minutes in writing to FDA within 10 calendar days of receipt of the
official meeting minutes. This process addresses issues with the meeting minutes only.
If an applicant needs to discuss additional issues that were not addressed at the meeting or
teleconference, the applicant should submit a controlled correspondence or a new meeting
request, as appropriate.
If, after following up as described above, there are still significant differences in the applicant’s
and FDA’s understanding of the content of the official meeting minutes, the applicant should
notify FDA in writing with respect to specific disagreements. The applicant should submit the
correspondence to its application or, if there is no application, submit a letter to the division
director of the division that chaired the meeting or teleconference, with a copy to the FDA point
of contact describing the concern.
The applicant’s concerns will be taken under consideration by the assessment discipline and
senior management if senior management were present at the meeting. If the minutes are
deemed to accurately and sufficiently reflect the meeting discussion, the FDA point of contact
will convey this decision to the applicant and the minutes will stand as the official
documentation of the meeting. If, after discussions with the prospective ANDA applicant or
ANDA applicant, FDA deems it necessary to change the official minutes, the changes will be

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documented in an addendum to the official minutes. The addendum will also document any
continued objections.66

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Any addendum will be shared with the applicant by FDA.

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