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DRAFT GUIDANCE 
 
This guidance document is being distributed for comment purposes only.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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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 301-796-
9193.   
 
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., 4th 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Draft  Not for Implementation 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 
Draft  Not for Implementation 
 
Product-Specific Guidance Meetings Between FDA and ANDA 
1 
Applicants Under GDUFA 
2 
Guidance for Industry1 
3 
4   
5   
6  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
7  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
8  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
9  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
10  for this guidance as listed on the title page.   
11   
12   
13   
14   
15  I.  INTRODUCTION 
16   
17  This guidance provides recommendations to industry on product-specific guidance (PSG) 
18  meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant 
19  that has submitted to FDA an abbreviated new drug application (ANDA) under section 505(j) of 
20  the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).2  Specifically, this 
21  guidance provides information on requesting and conducting PSG meetings with FDA (PSG 
22  teleconferences, pre-submission PSG meetings, and post-submission PSG meetings), as 
23  contemplated in the Generic Drug User Fee Amendments (GDUFA) Reauthorization 
24  Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III 
25  commitment letter).3  And this guidance is intended to provide procedures that will promote 
26  well-managed PSG meetings and help ensure that such meetings are scheduled and conducted in 
27  accordance with the time frames set forth in the GDUFA III commitment letter.  
28   
29  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
30  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
31  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
32  the word should in Agency guidance means that something is suggested or recommended, but 
33  not required.  
34   
35     
 
 
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.   
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
36   
37  II.  BACKGROUND 
38   
39  The Generic Drug User Fee Amendments of 2012 (GDUFA I)4 amended the FD&C Act to 
40  authorize FDA to assess and collect user fees to provide the Agency with resources to help 
41  ensure patients have access to quality, safe, and effective generic drugs.  GDUFA fee resources5 
42  bring greater predictability and timeliness to the review of generic drug applications.  GDUFA 
43  has been reauthorized every 5 years to continue FDAs ability to assess and collect GDUFA fees 
44  and this user fee program has been reauthorized two times since GDUFA I, most recently in the 
45  Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023.6  As described 
46  in the GDUFA III commitment letter applicable to this latest reauthorization, FDA has agreed to 
47  performance goals and program enhancements regarding aspects of the generic drug assessment 
48  program that build on previous authorizations of GDUFA.  New enhancements to the program 
49  are designed to maximize the efficiency and utility of each assessment cycle, with the intent of 
50  reducing the number of assessment cycles for ANDAs and facilitating timely access to generic 
51  medicines for American patients. 
52   
53  To receive approval for an ANDA, an applicant generally must demonstrate, among other things, 
54  that its proposed drug product is bioequivalent to the reference listed drug (RLD).7  As noted in 
55  21 CFR 320.24, in vivo and/or in vitro methods can be used to establish bioequivalence (BE).  
56  FDA recommends that applicants consult published PSGs when considering an appropriate BE 
57  study and/or other studies for a proposed drug product.8, 9  PSGs provide recommendations for 
58  developing generic drug products and describe FDAs current thinking on the evidence needed to 
59  demonstrate that an ANDA is therapeutically equivalent to a specific RLD product.   
60   
61  As described in the GDUFA III commitment letter, FDA agreed to certain time frames and 
62  procedures for scheduling and conducting: (1) PSG teleconferences to provide feedback on the 
63  potential impact of a new or revised PSG on the applicants development program; and (2) pre-
 
 
4 Title III of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144. 
5 User fees are available for obligation 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 FDAs 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/guidances-
drugs/product-specific-guidances-generic-drug-development.  
9 In addition to consulting published PSGs, FDA also recommends that applicants consult FDAs 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-specific-
guidances-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 SubmissionsRefuse-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. 
2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
64  submission PSG meetings and post-submission PSG meetings to provide a forum in which the 
65  applicant can discuss the scientific rationale for an approach other than the approach 
66  recommended in the PSG to ensure that the approach complies with the relevant statutes and 
67  regulations.10  
68   
69   
70  III.  MEETING TYPES 
71   
72  As described in the GDUFA III commitment letter, there are three types of PSG meetings that 
73  occur between applicants and FDA: PSG teleconferences (which includes pre-submission PSG 
74  teleconferences and post-submission PSG teleconferences), pre-submission PSG meetings, and 
75  post-submission PSG meetings.  
76   
77  PSG teleconferences provide a forum for applicants to obtain FDAs feedback on the potential 
78  impact of a new or revised PSG on the applicants development program when the applicant has 
79  already commenced (i.e., the study protocol was signed by the study sponsor and/or the contract 
80  research organization) or completed an in vivo BE study.  A prospective ANDA applicant can 
81  request a pre-submission PSG teleconference prior to submission of the ANDA.  An ANDA 
82  applicant can request a post-submission PSG teleconference if the ANDA has been submitted.  
83  When FDA states in a PSG teleconference that a new or revised PSG would impact an 
84  applicants development program, this statement is an indicator that the applicant has already 
85  commenced or completed in vivo study alone is unlikely to be sufficient to demonstrate BE in 
86  accordance with the relevant statutes and regulations.  
87   
88  If an applicant seeks further feedback from FDA after a PSG teleconference to ensure that any 
89  proposed changes or additions to an applicants in vivo study would result in an approach that 
90  complies with the relevant statutes and regulations, the applicant may request a pre-submission 
91  PSG meeting or post-submission PSG meeting, as appropriate, to discuss the scientific rationale 
92  for an approach other than the approach recommended in the PSG.   
93   
94  As described in the GDUFA III commitment letter, a prospective ANDA applicant is eligible to 
95  have a pre-submission PSG meeting if it first requests and has a pre-submission PSG 
96  teleconference with FDA.11  The pre-submission PSG teleconference and the subsequent pre-
97  submission PSG meeting should occur before submission of the ANDA (i.e., within the pre-
98  submission phase) so that the prospective ANDA applicant obtains FDAs feedback on an 
99  approach other than the approach recommended in the PSG before submission of the ANDA.12 
100   
101  As described the GDUFA III commitment letter, an ANDA applicant is eligible to have a post-
102  submission PSG meeting if it first requests and has a post-submission PSG teleconference with 
 
 
10 GDUFA III commitment letter at 24.  
11 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, and then requests a post-submission PSG meeting.  FDA will not simultaneously assess the adequacy of 
an ANDAs demonstration of BE and consider and respond to questions submitted in a PSG meeting package.    
3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
103  FDA.13  The post-submission PSG teleconference and the subsequent post-submission PSG 
104  meeting should occur before responding to a possible BE deficiency identified in a discipline 
105  review letter (DRL) or a BE deficiency identified in a complete response letter (CRL).  For 
106  example, if FDA has issued a CRL, the ANDA applicant should request and attend the post-
107  submission PSG meeting prior to responding to the BE deficiency identified in the CRL so that 
108  the ANDA applicant can consider FDAs feedback in developing a response to the CRL.14, 15 
109   
110  As an alternative to a pre-submission PSG meeting or a post-submission PSG meeting, 
111  applicants can consider obtaining FDAs feedback on an approach other than the approach 
112  recommended in the PSG through controlled correspondence or another meeting type, as 
113  appropriate.16  FDA recommends that applicants consider the types of questions on which they 
114  want to obtain FDAs feedback, the status of their ANDA, and the eligibility criteria for 
115  controlled correspondence or a particular meeting type in determining which pathway to seek 
116  FDAs feedback.  Applicants should not submit multiple meeting requests or controlled 
117  correspondence at or around the same time with the same or similar questions.  If FDA receives 
118  multiple meeting requests or controlled correspondence that contain the same or similar 
119  question(s), FDA will determine which meeting to grant or controlled correspondence to answer 
120  and may deny the other(s).  
121   
122  A.  PSG Teleconferences 
123   
124  PSG teleconferences provide an opportunity for an applicant to obtain FDAs feedback on the 
125  potential impact of a new or revised PSG on the applicants development program when the 
126  applicant has already commenced an in vivo BE study.17  During a PSG teleconference, FDA 
127  will provide feedback on the potential impact of the recommendations in the PSG, but FDA will 
128  not discuss the applicants questions regarding an approach other than the approach 
129  recommended in the PSG.  During a PSG teleconference, FDA may, if applicable, recommend a 
130  path for future communication with FDA, such as controlled correspondence, pre-submission 
131  PSG meeting, post-submission PSG meeting, or other meeting type.   
132   
133  When FDA publishes a new or revised PSG which includes a recommendation to conduct an in 
134  vitro BE study only and an applicant has already commenced or completed an in vivo BE study, 
 
 
13 GDUFA III commitment letter at 24. 
14 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 ANDAs 
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 applicants 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.  
4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
135  FDA generally would consider the submission of the in vivo BE study as an acceptable approach 
136  for demonstrating BE.  Therefore, applicants in such a situation in general should not request a 
137  PSG teleconference, but FDA recommends, to ensure the ANDA submission is acceptable for 
138  receipt and scientific review, that an applicant in such a situation include supporting information 
139  with its ANDA to justify the in vivo approach used that deviates from the in vitro approach 
140  recommended in the PSG to demonstrate BE.18 
141   
142  Applicants should submit a request for a PSG teleconference within 60 days after publication of 
143  the new or revised PSG so that FDA can provide timely feedback to applicants.19  Applicants can 
144  request a PSG teleconference more than 60 days after publication of the new or revised PSG, 
145  however, the 30-day time frame for conducting PSG teleconferences20 (discussed in section IV 
146  of this guidance) is only applicable for complete packages submitted within 60 days after 
147  publication of the PSG and otherwise meet the criteria set forth in section V of this guidance.   
148   
149  1.  Pre-Submission PSG Teleconferences 
150   
151  A prospective ANDA applicant can request a pre-submission PSG teleconference when FDA 
152  publishes a new or revised PSG that introduces or revises a recommendation related to an in vivo 
153  BE study, the ANDA has not been submitted, and the prospective ANDA applicant has already 
154  commenced an in vivo BE study as of the published date for the new or revised PSG (i.e., the 
155  study protocol was signed by the study sponsor and/or the contract research organization before 
156  the PSG publication date).21  With the pre-submission PSG teleconference request, a prospective 
157  ANDA applicant should submit the title page, protocol summary, and the signature page of the 
158  relevant in vivo BE study protocol signed and dated by the study sponsor and/or the contract 
159  research organization (see section V.A for additional information on the contents for the meeting 
160  request).22   
161   
162  After a pre-submission PSG teleconference has been held, a prospective ANDA applicant can 
163  request a pre-submission PSG meeting (if the ANDA has not been submitted), utilize the 
164  controlled correspondence process, or request another meeting type, as appropriate, to seek 
165  further feedback from FDA regarding an alternative BE approach to the recommendations in the 
166  PSG.23, 24    
167   
 
 
18 See footnote 9. 
19 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 PSGs availability publishes in the Federal Register. 
20 GDUFA III commitment letter at 24.  
21 Ibid.  
22 Ibid.  
23 Ibid.   
24 See footnote 16.    
5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
168  2.  Post-Submission PSG Teleconferences 
169   
170  An ANDA applicant can request a post-submission PSG teleconference when FDA publishes a 
171  new or revised PSG that introduces or revises a recommendation related to an in vivo BE study, 
172  the ANDA has been submitted, and an applicant has already commenced or completed an in vivo 
173  BE study (i.e., the study protocol has been signed by the study sponsor and/or the contract 
174  research organization before the PSG publication date).25   
175   
176  FDA also intends to offer the opportunity for a post-submission PSG teleconference in the 
177  following two situations, which are not described in the GDUFA III commitment letter: 
178   
179    An ANDA applicant can request a post-submission PSG teleconference when FDA 
180  publishes a new PSG which includes a recommendation to conduct an in vivo BE study 
181  and the ANDA applicant did not conduct an in vivo BE study.26   
182   
183    An ANDA applicant can request a post-submission PSG teleconference when FDA 
184  publishes a revised PSG which includes a recommendation to conduct an in vivo BE 
185  study, the previous PSG did not include a recommendation to conduct an in vivo BE 
186  study, and the ANDA applicant commenced or completed the in vitro BE study or studies 
187  either that were recommended by FDA in the previous PSG or that the ANDA applicant 
188  decided to pursue after a prior product development meeting.27 
189   
190  After a post-submission PSG teleconference has been held, an ANDA applicant can request a 
191  post-submission PSG meeting (discussed in more detail below), utilize the controlled 
192  correspondence process, or request another meeting type, as appropriate, to seek further feedback 
193  from FDA regarding an alternative BE approach to the recommendations in the PSG.28   
194   
195  B.  Pre-Submission PSG Meetings 
196   
197  After a pre-submission PSG teleconference has been held and if the ANDA has not been 
198  submitted, the prospective ANDA applicant can request a pre-submission PSG meeting.  The 
199  purpose of the pre-submission PSG meeting is to provide a forum in which the prospective 
200  ANDA applicant can discuss the scientific rationale for an approach other than the approach 
201  recommended in the PSG to ensure that the approach complies with the relevant statutes and 
202  regulations.29  During a pre-submission PSG meeting, FDA will discuss the prospective ANDA 
203  applicants questions related to their proposed alternative BE approach which differs from the 
 
 
25 GDUFA III commitment letter at 24.  
26 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 FDAs 
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.  
6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
204  recommendations in the current PSG.  FDA will not discuss questions unrelated to the alternative 
205  BE approach to the recommendations in the current PSG.   
206   
207  Prospective ANDA applicants should request a pre-submission PSG meeting in a timely manner 
208  after the pre-submission PSG teleconference, considering the time needed to develop the meeting 
209  package for a pre-submission PSG meeting with FDA, and before submitting the ANDA.  
210  Prospective ANDA applicants can request a pre-submission PSG meeting regardless of whether 
211  they have had a product development meeting.30   
212   
213  As an alternative to requesting a pre-submission PSG meeting after a pre-submission PSG 
214  teleconference, prospective ANDA applicants can consider submitting controlled 
215  correspondence or requesting another meeting type, such as a product development meeting, as 
216  appropriate, to seek feedback from FDA.31 
217   
218  C.  Post-Submission PSG Meetings 
219   
220  After a post-submission PSG teleconference has been held, the ANDA applicant can request a 
221  post-submission PSG meeting.32  The purpose of the post-submission PSG meeting is to provide 
222  a forum in which ANDA applicants can discuss the scientific rationale for an approach other 
223  than the approach recommended in the PSG to ensure that the approach complies with the 
224  relevant statutes and regulations.33  During a post-submission PSG meeting, FDA will discuss 
225  the ANDA applicants questions related to their proposed alternative BE approach which differs 
226  from the recommendations in the current PSG.  FDA will not discuss questions unrelated to the 
227  proposed alternative BE approach to the recommendations in the current PSG.   
228   
229  FDA recommends that an ANDA applicant consider the status of the ANDA and its assessment 
230  cycle as well as the time needed to develop the meeting package in determining when to submit a 
231  request for a post-submission PSG meeting.  For example, FDA recommends that an ANDA 
232  applicant refrain from requesting the post-submission PSG meeting during the assessment cycle 
233  until after FDA has issued a DRL or a CRL to allow FDA to complete its scientific evaluation of 
234  the ANDA applicants submitted evidence of BE.34  Between assessment cycles (e.g., FDA 
235  previously issued a CRL to the ANDA applicant and the post-submission PSG teleconference 
236  was subsequently held), FDA recommends that the ANDA applicant request the post-submission 
237  PSG meeting once the ANDA applicant has developed the meeting package.  If an ANDA 
238  applicant intends to request a post-submission PSG meeting, the ANDA applicant should request 
 
 
30 Ibid at 25.   
31 See footnote 16.  
32 ANDA applicants 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 ANDAs demonstration of BE and consider and respond 
to questions submitted in a PSG meeting package.  
7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
239  and attend the post-submission PSG meeting prior to responding to the possible BE deficiency 
240  identified in a DRL or the BE deficiency identified in the CRL.35  
241   
242  During the assessment cycle, as an alternative to a post-submission PSG meeting, ANDA 
243  applicants can consider submitting controlled correspondence or requesting another meeting 
244  type, such as an enhanced mid-cycle review meeting, as appropriate, to seek feedback from FDA 
245  after a post-submission PSG teleconference.36  After a CRL, as an alternative to a post-
246  submission meeting, ANDA applicants can consider submitting controlled correspondence or 
247  requesting another meeting type, such as a post-CRL scientific meeting, as appropriate, to seek 
248  feedback from FDA.37 
249   
250   
251  IV.  GDUFA III PERFORMANCE GOALS 
252   
253  As reflected in the GDUFA III commitment letter, FDA committed to certain goals and 
254  procedures for scheduling and conducting PSG teleconferences, pre-submission PSG meetings, 
255  and post-submission PSG meetings for ANDAs.38, 39  Applicants can request PSG 
256  teleconferences for PSGs published on or after October 1, 2022.40  The goals described below 
257  only apply to requests submitted on or after October 1, 2022, and subject to the criteria described 
258  in this guidance.  
259   
260  FDA agreed to hold a PSG teleconference within 30 days after the receipt of the meeting request 
261  if the request is granted.41  This goal only applies to PSG teleconference requests submitted 
262  within 60 days after the PSG publication.42 
263   
264  For pre-submission PSG meetings, FDA agreed to grant or deny the meeting request within 14 
265  days after FDA has received the request.43  If granted, FDA agreed to hold the pre-submission 
266  PSG meeting within 120 days after FDA received the request.44  
 
 
35 See footnote 14.  ANDA applicants 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 FDAs 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 FDAs guidance for industry Providing Regulatory Submissions 
in Electronic FormatReceipt 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.   
8  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
267   
268  For post-submission PSG meetings, FDA agreed to grant or deny the meeting request within 14 
269  days after FDA has received the request.45  If granted, FDA agreed to hold the post-submission 
270  PSG meeting within 90 days after FDA received the request.46   
271   
272   
273  V.  MEETING REQUESTS 
274   
275  A request for a PSG teleconference, pre-submission PSG meeting, and post-submission PSG 
276  meeting should be submitted electronically, as explained below in this section.   
277   
278  Requests for a pre-submission PSG meeting can be submitted after the prospective ANDA 
279  applicant had a pre-submission PSG teleconference and if the ANDA has not been submitted.  
280  The pre-submission PSG meeting request should clearly indicate that the prospective ANDA 
281  applicant had a pre-submission PSG teleconference with FDA. 
282   
283  Requests for a post-submission PSG meeting can be submitted after the ANDA applicant had a 
284  post-submission PSG teleconference.  The post-submission PSG meeting request should clearly 
285  indicate that the ANDA applicant had a post-submission PSG teleconference with FDA.   
286   
287  If FDA determines that the meeting request does not contain the information specified in this 
288  section, the request will not be considered to be submitted for purposes of GDUFA III 
289  performance goals.   
290   
291  An applicant should not request a PSG teleconference, pre-submission PSG meeting, or post-
292  submission PSG meeting if the applicant has requested or has been granted but not yet had 
293  another meeting with FDA, such as a pre-submission meeting, an enhanced mid-cycle review 
294  meeting, or a post-CRL scientific meeting.  FDA also recommends that applicants not submit a 
295  controlled correspondence and a request for a pre-submission PSG meeting or a post-submission 
296  PSG meeting at or around the same time with the same or similar questions.  If FDA receives 
297  multiple requests that contain the same or similar question(s), FDA intends to determine which 
298  request to grant and may deny the other(s).   
299   
300  A.  PSG Teleconferences 
301   
302  A prospective ANDA applicant should submit a request for a pre-submission PSG teleconference 
303  electronically through the CDER Direct NextGen Collaboration Portal.47  An ANDA applicant 
304  should submit a request for a post-submission PSG teleconference electronically through the 
305  Enterprise Submission Gateway.  The cover page should identify the submission as a PSG 
306  Teleconference Request.  
307   
 
 
45 Ibid.  
46 Ibid. 
47 The CDER Direct NextGen Collaboration Portal may be accessed at https://edm.fda.gov.   
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308  A request for a PSG teleconference meeting should include the following information: 
309   
310  (1)  Pre-assigned ANDA number48 or ANDA number.  
311   
312  (2)  Meeting type being requested (i.e., PSG Teleconference). 
313   
314  (3)  Month and year the current PSG was published. 
315   
316  (4)  A summary of how the applicants BE study(ies) differ from the study(ies) 
317  recommended in the PSG. 
318   
319  (5)  Signature page of the relevant in vivo BE study protocol signed by the study sponsor 
320  and/or contract research organization, if applicable.49    
321   
322  (6)  RLD and its application number. 
323   
324  (7)  Established Name.  
325   
326  (8)  Proposed indication(s). 
327   
328  (9)  Dosage form, route of administration, and strength(s). 
329   
330  (10) A statement indicating whether the submission is being made by the applicant or by a 
331  U.S. agent on behalf of the applicant.  
332   
333  (11) Contact person for the meeting (i.e., the person submitting the request), with their title 
334  and affiliation, secure email address,50 and phone number.  This is the person with whom 
335  FDA will communicate about the meeting.  
336   
337  (12) The meeting package (see section VIII of this guidance), which should be received at the 
338  time of the meeting request. 
339     
 
 
48 See information regarding requesting a pre-assigned application number on FDAs 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.   
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340  B.  Pre-Submission PSG Meetings 
341   
342  A prospective ANDA applicant should submit a request for a pre-submission PSG meeting 
343  electronically through the CDER Direct NextGen Collaboration Portal.51  The cover page should 
344  identify the submission as a Pre-Submission PSG Meeting.    
345   
346  A request for a pre-submission PSG meeting should include the following information: 
347   
348  (1)  Pre-assigned ANDA number.  
349   
350  (2)  Meeting type being requested (i.e., pre-submission PSG meeting).  
351   
352  (3)  RLD and application number. 
353   
354  (4)  Established Name.  
355   
356  (5)  Proposed indication(s).  
357   
358  (6)  Dosage form, route of administration, and strength(s). 
359   
360  (7)  Date pre-submission PSG teleconference was held and event ID.  
361   
362  (8)  A statement indicating whether the submission is being made by the prospective ANDA 
363  applicant or by a U.S. agent on behalf of the prospective ANDA applicant.   
364   
365  (9)  Contact person for the meeting (i.e., the person submitting the request), with their title 
366  and affiliation, secure email address,52 and phone number.  This is the person with whom 
367  FDA will communicate about the meeting.   
368   
369  (10) The meeting package (see section VIII of this guidance), which should be received at the 
370  time of the meeting request.  
371   
372  C.  Post-Submission PSG Meetings 
373   
374  An ANDA applicant should submit a request for a post-submission PSG meeting electronically 
375  through the Enterprise Submission Gateway.  The cover page should identify the submission as a 
376  Post-Submission PSG Meeting. 
377   
378  A request for a post-submission PSG meeting should include the following information: 
379   
380  (1)  ANDA number.  
381   
 
 
51 See footnote 47.   
52 See footnote 50.   
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382  (2)  Meeting type being requested (i.e., post-submission PSG meeting). 
383   
384  (3)  RLD and application number. 
385   
386  (4)  Established Name.  
387   
388  (5)  Proposed indication(s). 
389   
390  (6)  Dosage form, route of administration, and strength(s). 
391   
392  (7)  Date post-submission PSG teleconference was held and event ID 
393   
394  (8)  Title and study number of the study impacted by the recommendations in the PSG.  
395   
396  (9)  A statement indicating whether the submission is being made by the ANDA applicant or 
397  by a U.S. agent on behalf of the ANDA applicant.   
398   
399  (10) Contact person for the meeting (i.e., the person submitting the request), with their title 
400  and affiliation, secure email address,53 and phone number.  This is the person with whom 
401  FDA will communicate about the meeting.   
402   
403  (11) The meeting package (see section VIII of this guidance), which should be received at the 
404  time of the meeting request.   
405   
406   
407  VI.  EVALUATING MEETING REQUESTS 
408   
409  FDA will determine whether to grant a PSG teleconference, pre-submission PSG meeting, or 
410  post-submission PSG meeting, and a response will be provided to the applicant by granting or 
411  denying the meeting request pursuant to the performance goals stated in the GDUFA III 
412  commitment letter (see section IV of this guidance) and as described below.  Although applicants 
413  can request a particular meeting type and format, FDA evaluates each meeting request and 
414  determines whether the request should be granted, the final meeting type, and the appropriate 
415  format.  
416   
417  A.  Meeting Request Denied 
418   
419  If a meeting request is denied, written notification to the applicant will include an explanation of 
420  the reason for the denial.   
421   
422  Denials of meeting requests submitted in conformity with the GDUFA III performance goals will 
423  be based on a substantive reason.  For example:   
424   
 
 
53 See footnote 50.   
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425    FDA may deny a PSG teleconference request if the applicants in vivo BE study started 
426  after the PSG was published or the request is incomplete (e.g., does not include the 
427  signature page of the relevant in vivo study protocol signed by the study sponsor and/or 
428  the contract research organization).  
429   
430    FDA intends to deny a pre-submission PSG meeting request if the prospective ANDA 
431  applicant did not have a pre-submission PSG teleconference or if the applicant submitted 
432  the ANDA after the pre-submission PSG teleconference.  In addition, FDA may deny the 
433  request if the request is incomplete, FDA determines that the inquiry would be 
434  appropriately addressed through a controlled correspondence, or the prospective ANDA 
435  applicant submitted the same or similar questions in a request for another meeting type or 
436  in controlled correspondence.54 
437   
438    FDA intends to deny a post-submission PSG meeting request if the ANDA applicant did 
439  not have a post-submission PSG teleconference or if the ANDA applicant had a pre-
440  submission PSG teleconference and then submitted the ANDA.  In addition, FDA may 
441  deny the request if the request is incomplete, FDA determines the inquiry would be 
442  appropriately addressed through a controlled correspondence, FDA determines that the 
443  questions in the meeting package have been addressed during the ANDA assessment, the 
444  ANDA applicant responded to the possible BE deficiency identified in a DRL or BE 
445  deficiency identified in a CRL, or the ANDA applicant submitted the same or similar 
446  questions in a request for another meeting type or in controlled correspondence.  
447   
448  FDA may grant a pre-submission PSG meeting request or post-submission PSG meeting request 
449  after a controlled correspondence response was issued if FDA determines that any issue(s) 
450  remain unresolved or would be more appropriately resolved in a pre-submission PSG meeting or 
451  post-submission PSG meeting.55   
452   
453  If a meeting request is denied, a subsequent request to schedule a PSG teleconference, pre-
454  submission PSG meeting, or post-submission PSG meeting will be considered as a new request 
455  (i.e., a request that is assigned a new set of time frames as described in section IV of this 
456  guidance, GDUFA III Performance Goals).   
457   
458  B.  Meeting Request Granted 
459   
460  If a request for a meeting is granted, FDA will provide written notification to the applicant of the 
461  decision.  FDA may indicate that the request is granted in part for the questions that are 
462  appropriate for the meeting type requested and denied in part for the questions that are not 
463  appropriate for the meeting type requested.  If FDA will be providing written responses only 
464  instead of holding a meeting or teleconference, FDA will advise the applicant that a written 
465  response only is forthcoming.  If FDA plans to hold a meeting or teleconference, FDA will 
466  schedule the meeting or teleconference by determining the date, time, length, format, and 
 
 
54 GDUFA III commitment letter at 25.   
55 Ibid.  
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467  expected FDA participants.  The scheduling information will be forwarded to the applicant either 
468  with the notification granting the meeting or teleconference or as soon as possible following 
469  notification that the request has been granted, and the meeting or teleconference will be 
470  scheduled within the GDUFA III performance goals (see section IV of this guidance).   
471   
472   
473  VII.  RESCHEDULING AND CANCELING MEETINGS 
474   
475  A.  Rescheduling Meetings 
476   
477  Occasionally, circumstances may arise that necessitate the rescheduling of a meeting.  If a 
478  meeting needs to be rescheduled, FDA will work to reschedule it as soon as possible after the 
479  original date.  A new meeting request should not be submitted.  Applicants and FDA should take 
480  reasonable steps to avoid rescheduling meetings.  For example, if an attendee becomes 
481  unavailable, a substitute can be identified, or comments on the topic that the attendee would have 
482  addressed can be forwarded to the applicant following the meeting.  It will be at FDAs 
483  discretion whether the meeting should be rescheduled depending on the specific circumstances. 
484   
485  A meeting may be rescheduled by FDA if, for example: 
486   
487  (1)  The assessment team determines that additional information is needed from the applicant 
488  to address the applicants questions.   
489   
490  (2)  Essential attendees are no longer available for the scheduled date and time because of an 
491  emergency.  
492   
493  (3)  Attendance by additional FDA offices not originally anticipated or requested by the 
494  applicant is critical and the offices availability precludes holding the meeting on the 
495  original date.   
496   
497  (4)  There is a regulatory policy issue that is yet to be resolved that may affect the response 
498  to the applicants questions.   
499   
500  (5)  The Federal Government is closed or opening is delayed due to inclement weather, 
501  emergency, or other reason.    
502   
503  B.  Canceling Meetings 
504   
505  Occasionally, circumstances may arise that necessitate the canceling of a meeting.  If a meeting 
506  is canceled, a subsequent request to schedule a meeting will be considered a new request.  
507  Applicants and FDA should take reasonable steps to avoid canceling meetings (unless the 
508  meeting is no longer necessary).  It will be at FDAs discretion whether the meeting should be 
509  canceled depending on the specific circumstances.   
510   
511  A pre-submission PSG teleconference may be canceled if, for example: 
512   
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513  (1)  The prospective ANDA applicant withdraws the request, or 
514   
515  (2)  The prospective ANDA applicant submits the ANDA  
516   
517  A post-submission PSG teleconference may be canceled if, for example: 
518   
519  (1)  The ANDA applicant withdraws the request, or  
520   
521  (2)  FDA refuses to receive the ANDA  
522   
523  A pre-submission PSG meeting may be canceled if, for example: 
524   
525  (1)  The prospective ANDA applicant withdraws the request 
526   
527  (2)  The prospective ANDA applicant informs FDA that its questions have been adequately 
528  answered by the preliminary written comments, or 
529   
530  (3)  The prospective ANDA applicant submits the ANDA  
531   
532  A post-submission PSG meeting may be canceled if, for example: 
533   
534  (1)  The ANDA applicant withdraws the request  
535   
536  (2)  FDA refuses to receive the ANDA  
537   
538  (3)  The ANDA applicant informs FDA that its questions have been adequately answered by 
539  the preliminary written comments, or  
540   
541  (4)  The ANDA applicant submits a response to the possible BE deficiency identified in a 
542  DRL or the BE deficiency identified in the CRL  
543   
544  If an applicant cancels a meeting, FDA will count the performance goal as met.  If FDA cancels 
545  the meeting, the meeting request will not be counted for performance goal purposes. 
546   
547   
548  VIII.  MEETING PACKAGE CONTENT 
549   
550  The meeting package should provide information relevant to the discussion topics and enable 
551  FDA to prepare adequately for the meeting.  The meeting package should clearly indicate the 
552  meeting type the applicant is requesting and include adequate information for FDA to assess the 
553  potential utility of the meeting and to identify the appropriate staff that should attend the 
554  meeting.     
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555  A.  Timing of Submission 
556   
557  The meeting package for a PSG teleconference, pre-submission PSG meeting, or post-
558  submission PSG meeting should be submitted to FDA so that it is received concurrently with the 
559  meeting request.   
560   
561  B.  Where and How Many Copies of Meeting Packages To Submit 
562   
563  A prospective ANDA applicant should submit the meeting package for a pre-submission PSG 
564  teleconference or for a pre-submission PSG meeting electronically to the CDER Direct NextGen 
565  Collaboration Portal at the same time as the meeting request.   
566   
567  An ANDA applicant should submit the meeting package for a post-submission PSG 
568  teleconference or for a post-submission PSG meeting electronically via the Enterprise 
569  Submission Gateway at the same time as the meeting request.   
570   
571  It is not necessary to submit any paper copies of the meeting package.   
572   
573  C.  Meeting Package Content 
574   
575  The meeting package should provide information relevant to the product, development stage, and 
576  meeting type requested, in addition to any supplementary information needed to help FDA 
577  develop responses to issues raised by applicant.  The meeting package should contain sufficient 
578  detail to meet the intended meeting objectives.   
579   
580  To facilitate FDA review, the meeting package content should be organized according to the 
581  proposed agenda.  The meeting package should be a sequentially paginated document (individual 
582  sections can be numbered separately, so long as there is an overall pagination covering the whole 
583  submission) with a table of contents, appropriate indices, appendices, cross-references, and tabs 
584  differentiating sections.   
585   
586  1.  PSG Teleconferences 
587   
588  A meeting package for a PSG teleconference generally should include the following information: 
589   
590  (1)  Pre-assigned ANDA number or ANDA number.  
591   
592  (2)  Month and year the current PSG was published. 
593   
594  (3)  Signature page of the relevant in vivo BE study protocol signed by the study sponsor 
595  and/or contract research organization, if applicable.56 
596   
597  (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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598   
599  (5)  Established name.   
600   
601  (6)  Dosage form, route of administration, strength(s), and dosing regimen (frequency and 
602  duration). 
603   
604  (7)  A background section that includes the following: 
605   
606    A brief history of the development program. 
607   
608    The status of product development. 
609   
610    A brief statement of the purpose and objectives of the teleconference, including a 
611  brief background of the issues underlying the agenda, a description of how the 
612  applicants study differs from the recommendations in the PSG, and if applicable, a 
613  statement indicating that the applicants in vivo study is impacted by the new or 
614  revised PSG.   
615   
616    Summary of prior correspondence, meeting requests, and meetings with FDA 
617  regarding the specific drug product that the teleconference request is regarding.   
618   
619  (8)  The title page, protocol summary, and the signature page of the relevant in vivo study 
620  protocol signed by the study sponsor and/or the contract research organization, if 
621  applicable.  
622   
623  (9)  The requested format57teleconference58 or written response only.59  For requested 
624  teleconferences, the request package should also include the following information:   
625   
626    A proposed agenda outlining how the 60-minute time allotted for the PSG 
627  teleconference should be apportioned to each agenda item.  
628   
629    Suggested dates and times (e.g., morning or afternoon) for the teleconference that are 
630  within the time frame of the meeting type being requested (see section IV).  Non-
631  available dates and times should also be included.   
632   
 
 
57 For applicants that meet the criteria in the GDUFA III commitment letter for a PSG teleconference, FDA will 
generally grant the applicants 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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633    A list of all individuals, with their titles and affiliations, who will attend the requested 
634  meeting from the applicants organization, including consultants and interpreters.60   
635   
636  2.  Pre-Submission PSG Meetings 
637   
638  A meeting package for a pre-submission PSG meeting generally should include the following 
639  information: 
640   
641  (1)  Pre-assigned ANDA number. 
642   
643  (2)  Month and year the current PSG was published. 
644   
645  (3)  In vivo BE study protocol signature date, if applicable.  
646   
647  (4)  Title and study number of the study impacted by the recommendations in the PSG. 
648   
649  (5)  RLD and application number. 
650   
651  (6)  Established Name.  
652   
653  (7)  Dosage form, route of administration, strength(s), and dosing regimen (frequency and 
654  duration). 
655   
656  (8)  A background section that includes the following: 
657   
658    A brief history of the development program. 
659    The status of product development, including status of the in vivo study. 
660    A brief summary of the PSG teleconference discussion.  
661   
662  (9)  A brief statement of the purpose and objectives of the meeting.  This statement should 
663  include a brief background of the issues underlying the agenda and a description of how 
664  the applicants study differs from the recommendations in the PSG.  
665   
666  (10) The specific alternative approach to establishing BE, with justification, rationale, and 
667  data to support discussion.   
668   
 
 
60 The applicant should notify their point of contact (POC) immediately if the list of meeting participants from the 
applicants 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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669  (11) The requested formatface-to-face,61 videoconference,62 teleconference, or written 
670  response only.  For requested formats other than written response only, the request 
671  package should also include the following information:   
672   
673    A proposed agenda outlining how the 60-minute time allotted for the pre-submission 
674  PSG meeting should be apportioned to each proposed question. 
675   
676    Suggested dates and times (e.g., morning or afternoon) for the meeting that are within 
677  the time frame of the meeting type being requested (see section IV).  Non-available 
678  dates and times should also be included.   
679   
680    A list of all individuals, with their titles and affiliations, who will attend the requested 
681  meeting from the applicants organization, including consultants and interpreters.63   
682   
683  3.  Post-Submission PSG Meetings 
684   
685  A meeting package for a post-submission PSG meeting generally should include the following 
686  information: 
687   
688  (1)  ANDA number. 
689   
690  (2)  Month and year the current PSG was published. 
691   
692  (3)  In vivo BE study protocol signature date, if applicable.  
693   
694  (4)  RLD and application number. 
695   
696  (5)  Established Name.  
697   
698  (6)  Dosage form, route of administration, strength(s), and dosing regimen (frequency and 
699  duration). 
700   
701  (7)  A background section that includes the following: 
702   
703    A brief history of the development program. 
704   
705    The status of product development. 
 
 
61 Face-to-face meetings are those in which the majority of attendees participate in person at the FDA.  
62 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 applicants 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. 
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706   
707    A description of BE deficiencies, if any, received in previous assessment cycles. 
708   
709    A brief summary of the PSG teleconference discussion.   
710   
711  (1)  A brief statement of the purpose and objectives of the meeting.  This statement should 
712  include a brief background of the issues underlying the agenda and a description of how 
713  the applicants study differs from the recommendations in the PSG.   
714   
715  (2)  The specific alternative approach to establishing BE, with justification, rationale, and/or 
716  data to support discussion.   
717   
718  (3)  The proposed format64face-to-face, videoconference, teleconference, or written 
719  response only.  For requested formats other than written response only, the request 
720  package should also include the following information: 
721   
722    A proposed agenda outlining how the 60-minute time allotted for the post-submission 
723  PSG meeting should be apportioned to each proposed question. 
724   
725    Suggested dates and times (e.g., morning or afternoon) for the meeting that are within 
726  the time frame of the meeting type being requested (see section IV).  Non-available 
727  dates and times should also be included.   
728   
729    A list of all individuals, with their titles and affiliations, who will attend the requested 
730  meeting from the applicants organization, including consultants and interpreters.65   
731   
732   
733  IX.  PRE-MEETING COMMUNICATIONS WITH APPLICANTS  
734   
735  In general, FDA will not provide preliminary written comments in advance of a PSG 
736  teleconference.   
737   
738  For pre-submission PSG meetings and post-submission PSG meetings, if FDA is not providing a 
739  written response only to the applicant, FDA intends to provide preliminary written comments to 
740  the applicants 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 
applicants 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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741   
742  Communications before the meeting between applicants and FDA, including preliminary written 
743  comments, can serve as a foundation for discussion or as the final meeting responses if the 
744  meeting is canceled.  Nevertheless, preliminary written comments should not be construed as 
745  final unless there is agreement between the applicant and FDA that additional discussion is not 
746  necessary for any question (i.e., when the meeting is canceled because the applicant is satisfied 
747  with FDAs preliminary written comments), or the applicant and FDA agree a particular question 
748  is considered resolved, allowing extra time for discussion of other questions during the meeting.  
749  After receiving the preliminary written comments, the applicant should provide an updated 
750  agenda with its list of questions for discussion in order of priority, no later than 48 hours before 
751  the scheduled meeting.  Preliminary written comments communicated by FDA should not 
752  generate the submission of new questions, and new questions will not be entertained at the 
753  meeting.   
754   
755   
756  X.  PROCEDURES FOR CONDUCT OF MEETINGS 
757   
758  A.  Introductions and Agenda 
759   
760  PSG teleconferences will be chaired by an FDA staff member, will include a division director or 
761  designee from the generic drug program, and will begin with introductions and a statement of the 
762  agenda.  In general, the meeting participants will discuss the potential impact of the new or 
763  revised PSG on the applicants development program.   
764   
765  Pre-submission PSG meetings and post-submission PSG meetings will be chaired by an FDA 
766  staff member, will include a division director or designee from the generic drug program, and 
767  will begin with introductions and a statement of the agenda.  In general, the meeting participants 
768  will discuss questions posed and the data provided by the applicant.   
769   
770  B.  End of Meeting Summary 
771   
772  Before the end of the meeting, FDA attendees and the applicant attendees should summarize the 
773  important discussion points, agreements, clarifications, and action items.  Generally, the 
774  applicant will be asked to present the summary to ensure that there is mutual understanding of 
775  the meeting outcomes and action items.  FDA staff can add or further clarify any important 
776  points not covered in the summary, and these items can be added to the meeting minutes.  The 
777  summary can be done at the end of the meeting or after discussion of each question.   
778   
779  C.  Presentations 
780   
781  Presentations by applicants are not generally needed because the information necessary for 
782  review and discussion should be part of the meeting package.  If an applicant plans to make a 
783  presentation, the presentation should be discussed ahead of time with the FDA point of contact to 
784  ensure that FDA has the presentation materials ahead of the meeting, if possible.  All 
785  presentations should be kept brief to maximize the time available for discussion.   
786   
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787  The length of the meeting will not be increased to accommodate a presentation.  If a presentation 
788  contains more than a small amount of content distinct from clarifications or explanations of 
789  previous data or contains data that were not included in the original meeting package submitted 
790  to FDA for review, FDA staff may not be able to provide comments on the new information.   
791   
792  FDA does not expect that applicant attendees of a PSG teleconference will provide any 
793  presentations.   
794   
795   
796  XI.  DOCUMENTATION AND MEETING MINUTES 
797   
798  Documentation of meeting outcomes (responses to the questions and outcomes of any 
799  discussions regarding the responses), agreements, and disagreements is critical to ensuring that 
800  this information is preserved for meeting participants and for future reference.  FDA minutes are 
801  the official record of the meeting.  FDA intends to issue the official, finalized minutes to the 
802  applicant within 30 days after the PSG teleconference, pre-submission PSG meeting, or post-
803  submission PSG meeting.   
804   
805   
806  XII.  RESOLUTION OF DISPUTE ABOUT MEETING MINUTES 
807   
808  On occasion, there may be disputes regarding the accuracy and sufficiency of the minutes of a 
809  PSG teleconference, pre-submission PSG meeting, or post-submission PSG meeting.  An 
810  applicant requesting additional clarification of the meeting minutes issued by FDA should 
811  contact the assigned FDA point of contact.  FDA recommends that the applicant submit its 
812  concerns about the meeting minutes in writing to FDA within 10 calendar days of receipt of the 
813  official meeting minutes.  This process addresses issues with the meeting minutes only.   
814   
815  If an applicant needs to discuss additional issues that were not addressed at the meeting or 
816  teleconference, the applicant should submit a controlled correspondence or a new meeting 
817  request, as appropriate.   
818   
819  If, after following up as described above, there are still significant differences in the applicants 
820  and FDAs understanding of the content of the official meeting minutes, the applicant should 
821  notify FDA in writing with respect to specific disagreements.  The applicant should submit the 
822  correspondence to its application or, if there is no application, submit a letter to the division 
823  director of the division that chaired the meeting or teleconference, with a copy to the FDA point 
824  of contact describing the concern.  
825   
826  The applicants concerns will be taken under consideration by the assessment discipline and 
827  senior management if senior management were present at the meeting.  If the minutes are 
828  deemed to accurately and sufficiently reflect the meeting discussion, the FDA point of contact 
829  will convey this decision to the applicant and the minutes will stand as the official 
830  documentation of the meeting.  If, after discussions with the prospective ANDA applicant or 
831  ANDA applicant, FDA deems it necessary to change the official minutes, the changes will be 
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832  documented in an addendum to the official minutes.  The addendum will also document any 
833  continued objections.66    
 
 
66 Any addendum will be shared with the applicant by FDA. 
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