Formal Meetings 
Between the FDA and 
Sponsors or Applicants 
of PDUFA Products 
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DRAFT GUIDANCE  
 
This guidance document is being distributed for comment purposes only.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 90 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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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) Jennifer Mercier at 301-796-0957 
or (CBER) the Office of Communication, Outreach, and Development at 800-835-4709 or 240-
402-8010.  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
September 2023 
Procedural 
Revision 1 
 
20429586dft.docx 
08/29/23   
Formal Meetings 
Between the FDA and 
Sponsors or Applicants 
of PDUFA Products 
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 
 
and/or 
 
Office of Communication, Outreach, and Development  
Center for Biologics Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD  20993-0002 
Phone: 800-835-4709 or 240-402-8010; Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-
guidances 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
September 2023 
Procedural 
Revision 1 
 
   
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  MEETING TYPES ........................................................................................................... 2 
A.  Type A Meeting .............................................................................................................................. 2 
B.  Type B Meeting .............................................................................................................................. 3 
C.  Type B (EOP) Meeting .................................................................................................................. 3 
D.  Type C Meeting .............................................................................................................................. 4 
E.  Type D Meeting .............................................................................................................................. 4 
F.  INTERACT Meeting ..................................................................................................................... 5 
IV.  MEETING FORMATS .................................................................................................... 6 
V.  MEETING REQUESTS ................................................................................................... 6 
VI.  ASSESSING AND RESPONDING TO MEETING REQUESTS ................................ 9 
A.  Meeting Denied ............................................................................................................................ 10 
B.  Meeting Granted .......................................................................................................................... 10 
VII.  MEETING PACKAGE .................................................................................................. 11 
A.  Timing of Meeting Package Submission .................................................................................... 12 
B.  Where and How Many Copies of Meeting Packages to Send .................................................. 12 
C.  Meeting Package Content ............................................................................................................ 12 
VIII.  PRELIMINARY RESPONSES ..................................................................................... 14 
IX.  RESCHEDULING AND CANCELING MEETINGS ................................................ 14 
X.  MEETING CONDUCT .................................................................................................. 16 
XI.  MEETING MINUTES.................................................................................................... 16 
REFERENCES ............................................................................................................................ 19 
APPENDIX:  SUMMARY OF MEETING MANAGEMENT PROCEDURAL GOALS ... 20 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Formal Meetings Between the FDA and  
2  Sponsors or Applicants of PDUFA Products 
3  Guidance for Industry1 
4   
5   
6   
7  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
8  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
9  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
10  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
11  for this guidance as listed on the title page. 
12   
13   
14   
15  I.  INTRODUCTION  
16   
17  This guidance provides recommendations to industry on formal meetings between the Food and 
18  Drug Administration (FDA) and sponsors or applicants relating to the development and review 
19  of drug or biological drug products (hereafter referred to as products) regulated by the Center for 
20  Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research 
21  (CBER).  This guidance does not apply to abbreviated new drug applications, applications for 
22  biosimilar biological products, or submissions for medical devices.  For the purposes of this 
23  guidance, formal meeting includes any meeting that is requested by a sponsor or applicant 
24  (hereafter referred to as requester(s)) following the procedures provided in this guidance and 
25  includes meetings conducted in any format (i.e., in person face-to-face, virtual face-to-face 
26  (video conference), teleconference, and written response only (WRO) see in section IV, Meeting 
27  Formats). 
28   
29  This guidance discusses the principles of good meeting management practices and describes 
30  standardized procedures for requesting, preparing, scheduling, conducting, and documenting 
31  such formal meetings.  The general principles in this guidance may be extended to other 
32  nonapplication-related meetings with external constituents, insofar as this is possible.2 
33   
34  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
35  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
36  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
37  the word should in Agency guidances means that something is suggested or recommended, but 
38  not required.  
39   
 
1 This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) in cooperation with the 
Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.  
 
2 The guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants (December 2017) and 
the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products 
(June 2018) have been withdrawn. 
1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
40   
41  II.  BACKGROUND 
42   
43  Each year, FDA review staff participate in many meetings with requesters who seek advice 
44  relating to the development and review of investigational new drugs and biologics, and drug or 
45  biological product marketing applications.  Because these meetings often represent critical points 
46  in the drug and biological product development, it is important that there are efficient, consistent 
47  procedures for the timely and effective conduct of such meetings.  The good meeting 
48  management practices in this guidance are intended to provide consistent procedures that will 
49  promote well-managed meetings and to ensure that such meetings are scheduled within a 
50  reasonable time, conducted efficiently, and documented appropriately. 
51   
52  FDA review staff and requesters are expected to adhere to the meeting management goals that 
53  were established under reauthorizations of the Prescription Drug User Fee Act (PDUFA).3  They 
54  are described individually throughout this guidance and summarized in the Appendix.  
55   
56   
57  III.  MEETING TYPES4 
58   
59  There are six types of formal meetings under PDUFA that occur between requesters and FDA 
60  staff:  Type A, Type B, Type B (end of phase (EOP)), Type C, Type D, and Initial Targeted 
61  Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT). 
62   
63  A.  Type A Meeting  
64   
65  Type A meetings are those that are necessary for an otherwise stalled product development 
66  program to proceed or to address an important safety issue.  Reasons for a Type A meeting 
67  include the following:  
68   
69    Dispute resolution meetings as described in 21 CFR 10.75, 312.48, and 314.103 and in 
70  the guidance for industry and review staff Formal Dispute Resolution:  Sponsor Appeals 
71  Above the Division Level (November 2017).5 
72   
73    Meetings to discuss clinical holds:  (1) in which the requester seeks input on how to 
74  address the hold issues; or (2) in which a response to hold issues has been submitted, and 
 
3 See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, available at 
https://www.fda.gov/media/151712/download. 
 
4 The meeting types and goal dates were negotiated under the Prescription Drug User Fee Act (PDUFA) and apply 
to formal meetings between FDA staff and requesters of PDUFA products; they do not apply to meetings with 
CDER Office of Generic Drugs, CDER Office of Compliance, or CDER Office of Prescription Drug Promotion.  
See the Prescription Drug User Fee Act (PDUFA) web page at 
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm. 
 
5 We update guidances periodically.  For the most recent version of a guidance, check the FDA Drugs guidance web 
page at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs. 
2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
75  reviewed by the FDA, but the FDA and the requester agree that the development is 
76  stalled and a new path forward should be discussed. 
77   
78    Meetings that are requested after receipt of an FDA Nonagreement Special Protocol 
79  Assessment letter in response to protocols submitted under the special protocol 
80  assessment procedures as described in the guidance for industry Special Protocol 
81  Assessment (April 2018). 
82   
83    Post-action meetings requested within 3 months after receipt of an FDA regulatory action 
84  other than an approval (e.g., issuance of a complete response letter). 
85   
86    Meetings requested within 30 days of FDA issuance of a refuse-to-file letter.  To file an 
87  application over protest, applicants must first request and have this meeting (21 CFR 
88  314.101(a)(3)). 
89   
90  B.  Type B Meeting  
91   
92  Type B meetings are as follows: 
93   
94    Pre-investigational new drug application (pre-IND) meetings.  
95   
96    Pre-emergency use authorization meetings.  
97   
98    Pre-new drug application (pre-NDA)/pre-biologics license application (pre-BLA) 
99  meetings (21 CFR 312.47). 
100   
101    Post-action meetings requested 3 or more months after receipt of an FDA regulatory 
102  action other than an approval (e.g., issuance of a complete response letter, refuse to file). 
103   
104    Meetings regarding risk evaluation and mitigation strategies or postmarketing 
105  requirements that occur outside the context of the review of a marketing application. 
106   
107    Meetings held to discuss the overall development program for products granted 
108  breakthrough therapy or regenerative medicine advanced therapy (RMAT) designation 
109  status.  All subsequent meetings for breakthrough therapy or RMAT-designated products 
110  will be considered either Type B or possibly Type A meetings if the meeting request 
111  meets the criteria for a Type A meeting. 
112   
113  C.  Type B (EOP) Meeting 
114   
115  Type B (EOP) meetings are as follows: 
116   
117    Certain end-of-phase 1 meetings (i.e., for products that will be considered for marketing 
118  approval under 21 CFR part 312, subpart E, or 21 CFR part 314, subpart H, or similar 
119  products) 
120   
3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
121    End-of-phase 2 (i.e., pre-phase 3) meetings (21 CFR 312.47) 
122   
123  D.  Type C Meeting  
124   
125  A Type C meeting is any meeting other than a Type A, Type B, Type B (EOP), Type D, or 
126  INTERACT meeting regarding the development and review of a product, including  meetings to 
127  facilitate early consultations on the use of a biomarker as a new surrogate endpoint that has never 
128  been previously used as the primary basis for product approval in the proposed context of use. 
129   
130  E.  Type D Meeting 
131   
132  A Type D meeting is focused on a narrow set of issues that are used to discuss issues at key 
133  decision points to provide timely feedback critical to move the program forward (e.g., often one, 
134  but typically not more than two issues and associated questions).  Requests could include the 
135  following: 
136   
137    A follow-up question that raises a new issue after a formal meeting (i.e., more than just a 
138  clarifying question about an FDA response from a prior meeting) 
139   
140    A narrow issue on which the sponsor is seeking Agency input with only a few (e.g., three 
141  to five questions total) associated questions 
142   
143    A general question about an innovative development approach that does not require 
144  extensive, detailed advice 
145   
146  Type D meetings should be limited to no more than two focused topics.  If the sponsor has more 
147  than two focused topics or a highly complex single issue that includes multiple questions, a Type 
148  C meeting should be requested rather than requesting a Type D meeting.  A Type C meeting 
149  should also be requested when there are more questions than appropriate for a Type D meeting.  
150  Sponsors should not request several Type D meetings in temporal proximity instead of a single 
151  Type C meeting.  In addition, the issue should not require input from more than three disciplines 
152  or divisions.  If the scope of the meeting is broad or includes complex questions/issues that 
153  require input from more than three disciplines or divisions, or requires cross-center responses, or 
154  additional regulatory review, then FDA will inform the sponsor that the Agency will be 
155  converting the meeting to the appropriate meeting type (Type B or C) and the sponsor can either 
156  withdraw their request or accept the FDAs meeting-type conversion without resubmitting a new 
157  meeting request. 
158   
159  Examples and Scenarios 
160   
161    A sponsor has a specific question about an aspect of a complex or innovative trial design 
162  (e.g., innovative pediatric design approach) 
163   
164    A sponsor has a specific question about presenting data following a pre-BLA/NDA 
165  meeting  
166   
4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
167    A sponsor has a specific follow-up question about a new idea stemming from a Type C 
168  meeting  
169   
170   
171  F.  INTERACT Meeting 
172   
173  INTERACT meetings are intended for novel products and development programs that present 
174  unique challenges in early development (i.e., before filing of an IND or before having a pre-IND 
175  meeting).  The issues typically relate to IND requirements, for example, questions about design 
176  of IND-enabling toxicity studies (e.g., species, endpoints), complex manufacturing technologies 
177  or processes, development of innovative devices used with a drug or biologic, or the use of New 
178  Approach Methodologies.  INTERACT meetings are intended to facilitate IND-enabling efforts 
179  when the sponsor is facing a novel, challenging issue that might otherwise delay progress of the 
180  product toward entry into the clinic in the absence of this early FDA input.  The sponsor needs to 
181  have selected a specific investigational product or a product-derivation strategy to evaluate in a 
182  clinical study before requesting an INTERACT meeting. 
183   
184  Questions and topics within the scope of an INTERACT meeting include the following: 
185   
186    Questions for novel products and development programs that present unique challenges 
187  in early development for all CDER and CBER products (i.e., questions for which there is 
188  no existing guidance or other information in writing the company could reference from 
189  FDA). 
190   
191    Issues that a sponsor needs to address before a pre-IND meeting, including issues such as 
192  the following: 
193   
194    Choice of appropriate preclinical models or necessary toxicology studies for novel 

195  drug platforms or drug candidates 
196   
197    Chemistry, manufacturing, and controls issues or testing strategies aimed to 

198  demonstrate product safety adequate to support first-in-human study 
199   
200    Overall advice related to the design of proof-of-concept or other pilot 

201  safety/biodistribution studies necessary to support administration of an investigational 
202  product in a first-in-human clinical trial 
203   
204    General recommendations about a future first-in-human trial in a target clinical 

205  population for which the population is novel and there is no prior precedent or 
206  guidance 
207   
208    Recommendations on approach for further development of an early-stage product 

209  with limited chemistry, manufacturing, and controls; pharmacology/toxicology; 
210  and/or clinical data that were collected outside of a U.S. IND  
211   
212    Other topics that would be agreed upon by FDA 

5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
213   
214   
215   
216  IV.  MEETING FORMATS 
217   
218  There are four meeting formats:  In person face-to-face, virtual face-to-face, teleconference, and 
219  WRO, as follows: 
220   
221  1.  In person face-to-face  Core attendees6 from the FDA and the sponsor/applicant 
222  participate in person at the FDA; such meetings will be hybrid with a virtual component 
223  to allow non-core participants to join virtually.  Because the intent is that the primary 
224  discussion occurs face-to-face in person, all sponsors and FDA individuals who are key 
225  to such discussions (i.e., core attendees) should participate, if at all feasible, in person.  
226  Individuals expected to have a more peripheral role (e.g., may be called on to comment 
227  on a single question) may participate virtually.  If core sponsor personnel are suddenly 
228  unable to attend the in person meeting due to illness or unexpected travel issues, they can 
229  join the meeting virtually.  If core sponsor personnel are not planning to attend in person, 
230  the meeting should be requested as a virtual face-to-face meeting.   
231   
232  2.  Virtual face-to-face (video conference)  Attendees participate remotely via virtual 
233  meeting platform (e.g., Zoom) (with core attendees cameras on).   
234   
235  3.  Teleconference  Attendees participate via an audio only connection (e.g., telephone, 
236  virtual meeting platform without cameras on). 
237   
238  4.  Written Response Only (WRO)  Written responses are sent to requesters in lieu of 
239  meetings conducted in one of the other formats described above. 
240   
241   
242  V.  MEETING REQUESTS 
243   
244  To make the most efficient use of FDA resources, requesters should use the extensive sources of 
245  product development information that are publicly available before seeking a meeting (e.g., 
246  guidances).  To disseminate a broad range of information in a manner that can be easily and 
247  rapidly accessed by interested parties, the FDA develops and maintains web pages, portals, and 
248  databases, and participates in interactive media as a means of providing information on scientific 
249  and regulatory issues.   
250   
251  To promote efficient meeting management, requesters should try to anticipate future needs and, 
252  to the extent practical, address relevant and related product development issues in the fewest 
253  possible meetings while avoiding meetings with too many questions (or subparts of questions) 
254  that would be impractical to discuss in the context of any single meeting.  Furthermore, having 
 
6 FDA will have its core participants with a primary speaking roles participate in person while others may join 
virtually (see https://www.fda.gov/industry/prescription-drug-user-fee-amendments/update-person-face-face-formal-
meetings-fda). 
 
6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
255  too many questions is not recommended when the topics are complex or if the combined issues 
256  would involve voluminous material for FDA review.  As discussed below, there should generally 
257  be no more than 10 total questions to the FDA.  
258   
259  When a meeting is needed, a written request must be submitted to the FDA via the electronic 
260  gateway or, in CDER, via the CDER Nextgen Portal, as appropriate.7  For additional ways to 
261  submit to CBER, please see https://www.fda.gov/about-fda/about-center-biologics-evaluation-
262  and-research-cber/regulatory-submissions-electronic-and-paper.  Requests should be addressed 
263  to the appropriate Center and review division or office and, if previously assigned, submitted to 
264  the application (e.g., investigational new drug application (IND), new drug application (NDA), 
265  biologics license application (BLA), pre-application tracking system (PTS) Number (CBER)).  If 
266  necessary, noncommercial IND holders may also submit the meeting request via the appropriate 
267  centers document room. 
268   
269  The meeting request should include adequate information for the FDA to assess the potential 
270  utility of the meeting and to identify FDA staff necessary to discuss proposed agenda items.   
271   
272  The meeting request should include the following information: 
273   
274  1.  The application number (if previously assigned).  
275   
276  2.  The product name. 
277   
278  3.  The chemical name, established name, and/or structure. 
279   
280  4.  The proposed regulatory pathway (e.g., 505(b)(1), 505(b)(2)). 
281   
282  5.  The proposed indication(s) or context of product development. 
283   
284  6.  The meeting type being requested (i.e., Type A, Type B, Type B (EOP), Type C, Type D, 
285  or INTERACT). 
286   
287  7.  Pediatric study plans, if applicable. 
288   
289  8.  Human factors engineering plan, if applicable. 
290   
291  9.  Combination product information (e.g., constituent parts, including details of the device 
292  constituent part, intended packaging, planned human factors studies), if applicable.  
293   
294  10. Suggested dates and times (e.g., morning or afternoon) for the meeting that are consistent 
295  with the appropriate scheduling time frame for the meeting type being requested (see 
296  Table 2 in section VI.B., Meeting Granted).  Dates and times when the requester is not 
297  available should also be included. 
298   
 
7 See the guidance for industry Providing Regulatory Submissions in Electronic Format  Submissions Under 
Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (December 2014). 
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299  11. A list of proposed questions, grouped by FDA discipline.  For each question there should 
300  be a brief explanation of the context and purpose of the question. 
301   
302  The meeting request must include the following information:8  
303   
304  1.  The proposed meeting format (i.e., in person face-to-face, virtual face-to-face, 
305  teleconference, and WRO (see section IV, Meeting Formats)). 
306   
307  2.  The date the meeting package will be sent by the requester (see section VII.A., Timing of 
308  Meeting Package Submission).  Meeting packages should be included with the meeting 
309  request for all Type A meetings, Type C meetings where the objective is to facilitate 
310  early consultation on the use of a biomarker as a new surrogate endpoint that has never 
311  been previously used as the primary basis for product approval in the proposed context of 
312  use, all Type D meetings, and all INTERACT meetings. 
313   
314  3.  A brief statement of the purpose of the meeting that should include a background of the 
315  issues underlying the agenda and a summary of completed or planned studies and clinical 
316  trials or data that the requester intends to discuss at the meeting.  The statement should 
317  then include a description of the general issues being raised of the questions to be asked 
318  and where the meeting fits in overall development plans.  Although the statement should 
319  not provide the details of trial designs or completed studies and clinical trials, it should 
320  provide enough information to facilitate understanding of the issues, such as a small table 
321  that summarizes major results that are necessary to provide the FDA an understanding of 
322  the questions to be addressed at the meeting. 
323   
324  4.  A proposed agenda, including estimated time needed for discussion of each agenda item. 
325   
326  5.  A list of planned attendees from the requesters organization, including their names and 
327  titles.  The list should also include the names, titles, and affiliations of consultants and 
328  interpreters, if applicable. 
329   
330  6.  A list of requested FDA attendees and/or discipline representative(s).  Requests for 
331  attendance by FDA staff who are not otherwise essential to the applications review may 
332  affect the ability to hold the meeting within the specified time frame of the meeting type 
333  being requested.  Therefore, when attendance by nonessential FDA staff is requested, the 
334  meeting request should provide a justification for such attendees and state whether a later 
335  meeting date is acceptable to the requester to accommodate the nonessential FDA 
336  attendees. 
337   
338  A well-written meeting request that includes the above components can help the FDA understand 
339  and assess the utility and timing of the meeting related to product development or review.  The 
340  list of requester attendees and the list of requested FDA attendees can be useful in providing or 
341  preparing for the input needed at the meeting.  However, during the time between the request and 
342  the meeting, the planned attendees can change.  Therefore, an updated list of attendees with their 
 
8 See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, available at 
https://www.fda.gov/media/151712/download. 
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343  titles and affiliations should be included in the meeting package and a final list provided to the 
344  appropriate FDA contact before the meeting (see section VII.C., Meeting Package Content).   
345   
346  The objectives and agenda provide overall context for the meeting topics, but it is the list of 
347  questions that is most critical to understanding the kind of information or input needed by the 
348  requester, whether or not the questions can be feasibly addressed within the time frame 
349  associated with the meeting type requested, and to focus the discussion should the meeting be 
350  granted.  Each question should be precise and include a brief explanation of the context and 
351  purpose of the question.  The questions submitted within a single meeting request should be 
352  limited to those that can be reasonably answered within the allotted meeting time, taking into 
353  consideration the complexity of the questions submitted.  Similar considerations about the 
354  complexity of questions submitted within a WRO should be applied.  In general, there should be 
355  no more than 10 questions listed consecutively regardless of discipline.  The FDA requests that 
356  meeting requesters not submit subquestions, as they will be counted toward the overall number 
357  of questions.  For example, if Question 1 has three parts, the numbering should be 1, 2, and 3 
358  rather than numbering them 1a, 1b, and 1c (i.e., with each as subquestions).  If there are three 
359  clinical questions and three nonclinical questions, for a total of six questions, each question 
360  should have its own number (i.e., 1, 2, 3, 4, 5, 6, not Clinical 1, 2, 3 and then Nonclinical 1, 2, 3).  
361  The numbering of each question in the meeting request (see section VI, Assessing and 
362  Responding to Meeting Requests) should be identical to the numbering of each question in the 
363  meeting package.   
364   
365   
366  VI.  ASSESSING AND RESPONDING TO MEETING REQUESTS  
367   
368  For any type of meeting, the sponsor may request a WRO to its questions rather than another 
369  meeting format.  The FDA will review the request and make a determination on whether a WRO 
370  is appropriate or whether an in person face-to-face, virtual face-to-face, teleconference, or WRO 
371  (see section IV., Meeting Formats) meeting is necessary.  If a written response is requested and 
372  deemed appropriate, the FDA will notify the requester of the date it intends to send the written 
373  response in the Agencys response to the meeting request. 
374   
375  For pre-IND, Type C, Type D, and INTERACT meetings, although the sponsor may request an 
376  in-person, virtual, or teleconference meeting, the Agency may determine that a written response 
377  to the sponsors questions would be the most appropriate means for providing feedback and 
378  advice to the sponsor.  When it is determined that the meeting request can be appropriately 
379  addressed through a written response, the FDA will notify the requester of the date it intends to 
380  send the written response in the Agencys response to the meeting request.  If the sponsor 
381  believes a meeting is needed, the sponsor may provide a rationale in a follow-up correspondence 
382  to the division, explaining their rationale for the meeting.  The FDA will consider the follow-up 
383  correspondence and may or may not convert the WRO back to an appropriate format.  
384   
385  Requests for Type B and Type B (EOP) meetings will be honored if the sponsor is at the 
386  appropriate stage of development to make such a meeting productive.  For example, a request for 
387  an EOP2 meeting should clearly describe the status of the phase 2 trial(s) and whether summary 
388  efficacy and safety data from these trial(s) will be available in the briefing document, as the lack 
9  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
389  of these data will render an EOP2 meeting request premature.  With the exception of products 
390  granted breakthrough therapy or RMAT designation status, the FDA generally will not grant 
391  more than one of each of the Type B meetings for each potential application (e.g., IND, NDA, 
392  BLA) or combination of closely related products developed by the same requester (e.g., same 
393  active ingredient but different dosage forms being developed concurrently), but the FDA can do 
394  so when it would be beneficial to hold separate meetings to discuss unrelated issues.  For 
395  example, it may be appropriate to conduct more than one end-of-phase 2 meeting with different 
396  review divisions  or disciplines for concurrent development of a product for unrelated claims or a 
397  separate meeting to discuss manufacturing development when the clinical development is on a 
398  different timeline.  For novel programs, with many complex issues, discussion with the relevant 
399  division may lead to an agreement that additional meetings are needed. 
400   
401  A.  Meeting Denied 
402   
403  If a meeting request is denied, the FDA will notify the requester in writing according to the 
404  timelines described in Table 1.  The FDAs letter will include an explanation of the reason for 
405  the denial.  Denials will be based on a substantive reason, not merely on the absence of a minor 
406  element of the meeting request or meeting package items.  For example, a meeting can be denied 
407  because it is premature for the stage of product development or because the meeting package 
408  does not provide an adequate basis for the meeting discussion (see section IX., Rescheduling and 
409  Canceling Meetings, for the effect of inadequate meeting packages on other meeting types when 
410  the package is received after the meeting is granted).  The FDA may also deny requests for 
411  meetings that do not have substantive required elements described in section V., Meeting 
412  Requests.  A subsequent request to schedule the meeting will be considered as a new request 
413  (i.e., a request that merits a new set of time frames as described in section below, Meeting 
414  Granted).   
415   
416  B.  Meeting Granted 
417   
418  If a meeting request is granted, the FDA will notify the requester in writing according to the 
419  timelines described in Table 1.  For in person face-to-face, virtual face-to-face, and 
420  teleconference meetings, the FDAs letter will include the date, time, conferencing arrangements, 
421  and/or location of the meeting, as well as expected FDA participants.  For WRO requests, the 
422  FDAs letter will include the date the FDA intends to send the written responses (see Table 3 for 
423  FDA WRO response timelines).  As shown in Tables 2 and 3, FDA WRO response timelines are 
424  the same as those for scheduling an in-person face-to-face, virtual face-to-face, or teleconference 
425  meeting of the same meeting type. 
426   
427  For in person face-to-face, virtual face-to-face, and teleconference meetings, the FDA will 
428  schedule the meeting on the available date at which all expected FDA staff are available to 
429  attend; however, the meeting should be scheduled consistent with the type of meeting requested 
430  (see Table 2 for FDA meeting scheduling time frames).  If the requestors requested date for any 
431  meeting type is greater than the specified time frame, the meeting date should be scheduled by 
432  the FDA within 14 calendar days of that requested date. 
433   
434   
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435  Table 1.  FDA Meeting Request/WRO Request Response Timelines 
Meeting Type   Response Time  
(any format)  (calendar days from receipt of 
meeting request/WRO request) 
A  14 days 
B  21 days 
B (EOP)  14 days 
C  21 days 
D  14 days 
INTERACT  21 days 
436   
437  Table 2.  FDA Meeting Scheduling Time Frames 
Meeting Type  Meeting Scheduling  
(calendar days from receipt of 
meeting request) 
A  30 days  
B  60 days  
B (EOP)  70 days  
C  75 days  
D  50 days 
INTERACT  75 days 
438   
439  Table 3.  FDA WRO Response Timelines 
Meeting Type  WRO Response Time  
(calendar days from receipt of  
WRO request) 
A  30 days 
B  60 days 
B (EOP)  70 days 
C  75 days  
D  50 days 
INTERACT  75 days 
440   
441   
442  VII.  MEETING PACKAGE  
443   
444  Premeeting preparation is critical for achieving a productive discussion or exchange of 
445  information.  Preparing the meeting package should help the requester focus on describing its 
446  principal areas of interest.  The meeting package should provide information relevant to the 
447  discussion topics and enable the FDA to prepare adequately for the meeting.  In addition, the 
448  timely submission of the meeting package is important for ensuring that there is sufficient time 
449  for meeting preparation, accommodating adjustments to the meeting agenda, and accommodating 
450  appropriate preliminary responses to meeting questions.  Requestors are encouraged to include 
451  their meeting package for all meeting types, if possible, but must meet the required due dates for 
452  certain meetings (see Table 4 below).  
453   
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454  A.  Timing of Meeting Package Submission  
455   
456  Requesters must submit the meeting package for each meeting type (including WRO) according 
457  to the meeting package timelines described in Table 4.9  
458   
459  Table 4.  Requester Meeting Package Timelines 
Meeting  FDA Receipt of Meeting Package (calendar days) 
Type 
A, C*, D,  At the time of the meeting request  
INTERACT 
B  No later than 30 days before the scheduled date of the meeting 
or WRO response time 
B (EOP)  No later than 50 days before the scheduled date of the meeting 
or WRO response time** 
C  No later than 47 days before the scheduled date of the meeting 
or WRO response time*** 
460  *For Type C meetings that are requested as early consultations on the use of a new surrogate endpoint to be used as 
461  the primary basis for product approval in a proposed context of use, the meeting package is due at the time of the 
462  meeting request. 
463  ** If the scheduled date of a Type B (EOP) meeting is earlier than 70 days from FDA receipt of the meeting request, 
464  the requesters meeting package will be due no sooner than 6 calendar days after FDA response time for issuing the 
465  letter granting the meeting (see Table 1 in section VI.B., Meeting Granted). 
466  *** If the scheduled date of a Type C meeting is earlier than 75 days from FDA receipt of the meeting request, the 
467  meeting package will be due no sooner than 7 calendar days after FDA response time for issuing the letter granting 
468  the meeting (see Table 1 in section VI.B., Meeting Granted). 
469   
470  B.  Where and How Many Copies of Meeting Packages to Send 
471   
472  Requesters should submit the archival meeting package to the relevant application(s) (e.g., pre-
473  IND, IND, NDA, BLA or PTS (CBER)) via the electronic gateway or, in CDER, via the CDER 
474  Nextgen Portal (https://cdernextgenportal.fda.gov/), as applicable.10  For additional ways to 
475  submit to CBER, please see https://www.fda.gov/about-fda/about-center-biologics-evaluation-
476  and-research-cber/regulatory-submissions-electronic-and-paper.  If necessary, noncommercial 
477  IND holders may also submit the package via the appropriate centers document room. 
478   
479  C.  Meeting Package Content 
480   
481  The meeting package should provide summary information relevant to the product and any 
482  supplementary information needed to develop responses to issues raised by the requester or 
483  review division.  It is critical that the entire meeting package content support the intended 
484  meeting objectives.  The meeting package content will vary depending on the product, 
485  indication, phase of product development, and issues to be discussed.  FDA and ICH guidances 
 
9 See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, available at 
https://www.fda.gov/media/151712/download. 
 
10 See the guidances for industry Providing Regulatory Submissions in Electronic Format  Submissions Under 
Section 745A(a) of the Federal Food, Drug, and Cosmetic Act and Providing Regulatory Submissions in Electronic 
Format  General Considerations (January 1999). 
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486  identify and address many issues related to product development and should be considered when 
487  planning, developing, and providing information needed to support a meeting with the FDA.  If a 
488  product development plan deviates from current guidances, or from existing precedent, the 
489  deviation should be identified and explained.  Known difficult design and questions about 
490  providing substantial evidence of effectiveness should be raised for discussion (e.g., use of a 
491  surrogate endpoint, reliance on a single study, use of a noninferiority design, adaptive designs).  
492  Also, merely describing a result as significant does not provide the review division with enough 
493  information to give the most constructive advice or identify important problems the requester 
494  may have missed. 
495   
496  To facilitate FDA review, the meeting package content should be organized according to the 
497  proposed agenda.  The meeting package should be a sequentially paginated document with a 
498  table of contents with appropriate electronic linkage, appropriate indices, appendices, and cross 
499  references.  It should enhance reviewers navigation across different sections within the package, 
500  both in preparation for and during the meeting.  Meeting packages generally should include the 
501  following information, preferably in the order listed below:  
502   
503  Meeting packages should include the same first nine items provided for the meeting request (see 
504  above section V.), and in addition, should include: 
505   
506  1.  A list of all individuals, with their titles and affiliations, who will attend the requested 
507  meeting from the requesters organization, including consultants and interpreters. 
508   
509  2.  A background section that includes the following: 
510   
511  a.  A brief history of the development program and relevant communications with the 
512  FDA before the meeting 
513   
514  b.  Substantive changes in product development plans (e.g., new indication, population, 
515  basis for a combination), when applicable 
516   
517  c.  The current status of product development (e.g., drug development plan) 
518   
519  3.  A brief statement summarizing the purpose of the meeting and identifying the type of 
520  meeting, if applicable.  
521   
522  4.  A proposed agenda, including estimated time needed for discussion of each agenda item. 
523   
524  5.  A list of the final questions for discussion grouped by FDA discipline and with a brief 
525  summary for each question to explain the need or context for the question.   
526   
527  6.  Data to support discussion organized by FDA discipline and question.  Protocols, full 
528  study reports, or detailed data generally are not appropriate for meeting packages; the 
529  summarized material should describe the results of relevant studies and clinical trials with 
530  some degree of quantification and any conclusion about clinical trials that resulted.  The 
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531  trial endpoints should be stated, as should whether endpoints were altered or analyses 
532  changed during the course of the trial. 
533   
534  For example, for an end-of-phase 2 meeting, this section of the meeting package should 
535  include the following:  A description and the results of controlled trials conducted to 
536  determine dose-response information, summary efficacy and safety data from the phase 2 
537  trial(s); adequately detailed descriptors of planned phase 3 trials identifying major trial 
538  features such as population, critical exclusions, trial design (e.g., randomization, blinding, 
539  and choice of control group, with an explanation of the basis for any noninferiority 
540  margin if a noninferiority trial is used), dose selection, and primary and secondary 
541  endpoints; and major analyses (including planned interim analyses and adaptive features, 
542  and major safety concerns). 
543   
544   
545  VIII.  PRELIMINARY RESPONSES  
546   
547  Communications before the meeting between requesters and the FDA, including preliminary 
548  responses, can serve as a foundation for discussion or as the final meeting responses.  
549  Preliminary responses should not be construed as final unless there is agreement between the 
550  requester and the FDA that additional discussion is not necessary for any question (i.e., when the 
551  meeting is canceled because the responses and comments are clear to the requester), or a 
552  particular question is considered resolved allowing extra time for discussion of the more 
553  complex questions during the meeting.  Preliminary responses communicated by the FDA are not 
554  intended to generate the submission of new information or new questions.  If a requester 
555  nonetheless provides new data or a revised or new proposal, the FDA may not be able to provide 
556  comments on the new information, or it may necessitate the submission of a new meeting request 
557  by the requester. 
558   
559  The FDA holds an internal meeting to discuss the content of meeting packages and to gain 
560  internal alignment on the preliminary responses.  The FDA will send the requester its 
561  preliminary responses to the questions in the meeting package no later than 5 calendar days 
562  before the meeting date for Type B (EOP), Type C, Type D, and INTERACT meetings.  The 
563  requester will notify the FDA no later than 3 calendar days following receipt of the FDAs 
564  preliminary responses for these meeting types of whether the meeting is still needed, and if it is, 
565  the requester will send the FDA a revised meeting agenda indicating which questions the 
566  requestor considers as resolved and which questions the requestor will want to further discuss 
567  within the allotted time as reasonable.11  For Type A and Type B (other than Type B (EOP)), the 
568  FDA intends to send the requester its preliminary responses no later than 2 calendar days before 
569  the meeting.   
570   
571   
572  IX.  RESCHEDULING AND CANCELING MEETINGS 
573   
 
11 See PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, available at 
https://www.fda.gov/media/151712/download. 
14  Contains Nonbinding Recommendations 
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574  Occasionally, circumstances arise that necessitate rescheduling or canceling a meeting.  If a 
575  meeting needs to be rescheduled, it should be rescheduled as soon as possible after the original 
576  date.  A new meeting request should not be submitted.  However, if a meeting is canceled, the 
577  FDA will consider a subsequent request to schedule a meeting to be a new request (i.e., a request 
578  that merits a new set of time frames as described in section VI., Assessing and Responding to 
579  Meeting Requests).  Requesters and the FDA should take reasonable steps to avoid rescheduling 
580  and canceling meetings (unless the meeting is no longer necessary).  For example, if an attendee 
581  becomes unavailable, a substitute can be identified, or comments on the topic that the attendee 
582  would have addressed can be forwarded to the requester following the meeting.  It will be at the 
583  discretion of the review division whether the meeting should be rescheduled or canceled 
584  depending on the specific circumstances. 
585   
586  The following situations are examples of when a meeting can be rescheduled.  Some of the 
587  examples listed also represent reasons that a meeting may be canceled by the FDA.  This list 
588  includes representative examples and is not intended to be an exhaustive list. 
589   
590    The requester experiences any delay in submitting the meeting package.  The requester 
591  should contact the FDA project manager to explain why it cannot meet the time frames 
592  for submission and when the meeting package will be submitted. 
593   
594    The review team determines that the meeting package is inadequate, or additional 
595  information is needed to address the requesters questions or other important issues for 
596  discussion, but it is possible to identify the additional information needed and arrange for 
597  its timely submission. 
598   
599    There is insufficient time to review the material because the meeting package is 
600  voluminous (see section VII.C., Meeting Package Content), despite submission within the 
601  specified time frames and the appropriateness of the content. 
602   
603    After the meeting package is submitted, the requester sends the FDA additional questions 
604  or data that are intended for discussion at the meeting and require additional review time.  
605   
606    It is determined that attendance by additional FDA personnel not originally anticipated or 
607  requested is critical and their unavailability precludes holding the meeting on the original 
608  date. 
609   
610    Essential attendees are no longer available for the scheduled date and time because of an 
611  unexpected or unavoidable conflict or an emergency situation. 
612   
613  The following situations are examples of when a meeting can be canceled: 
614   
615    The meeting package is not received by the FDA within the specified time frames (see 
616  section VII.A., Timing of Meeting Package Submission) or is grossly inadequate.  
617  Meetings are scheduled on the condition that appropriate information to support the 
618  discussion will be submitted with sufficient time for review and preparatory discussion.  
619  Adequate planning should avoid this problem. 
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620   
621    The requester determines that preliminary responses to its questions are sufficient for its 
622  needs and additional discussion is not necessary (see section VIII., Preliminary 
623  Responses).  In this case, the requester should contact the FDA project manager to 
624  request cancellation of the meeting.  The FDA will consider whether it agrees that the 
625  meeting should be canceled.  Some meetings, particularly milestone meetings, can be 
626  valuable because of the broad discussion they generate and the opportunity for the 
627  division to ask about relevant matters (e.g., dose-finding, breadth of subject exposure, 
628  particular safety concerns), even if the preliminary responses seem sufficient to answer 
629  the requesters questions.  If the FDA agrees that the meeting can be canceled, the reason 
630  for cancellation will be documented and the preliminary responses will represent the final 
631  responses and the official record. 
632   
633   
634  X.  MEETING CONDUCT 
635   
636  Meetings will be chaired by an FDA staff member and begin with introductions and an overview 
637  of the agenda.  FDA policy prohibits audio or visual recording of discussions at meetings. 
638   
639  Presentations by requesters are usually unnecessary because the information necessary for 
640  review and discussion should be part of the meeting package.  If a requester plans to make a 
641  presentation, the presentation materials should be provided ahead of the meeting.  All 
642  presentations should be kept brief to maximize the time available for discussion.  The length of 
643  the meeting will not be increased to accommodate a presentation.  If a presentation contains 
644  more than a small amount of content distinct from clarifications or explanations of previous data 
645  and that were not included in the original meeting package submitted for review, FDA staff may 
646  not be able to provide commentary. 
647   
648  Either a representative of the FDA or the requester should summarize the important discussion 
649  points, agreements, clarifications, and action items.  Summation can be done at the end of the 
650  meeting or after the discussion of each question.  Generally, the requester will be asked to 
651  present the summary to ensure that there is mutual understanding of meeting outcomes and 
652  action items.  FDA staff can add or further clarify any important points not covered in the 
653  summary, and these items can be added to the meeting minutes.  At pre-NDA and pre-BLA 
654  meetings for applications reviewed under the PDUFA Program for Enhanced Review 
655  Transparency and Communication for New Molecular Entity (NME) NDAs and Original BLAs 
656  (also known as the Program),12 the requester and the FDA should also summarize agreements 
657  regarding the content of a complete application and any agreements reached on delayed 
658  submission of certain minor application components.   
659   
660   
661  XI.  MEETING MINUTES 
662   
663  Because the FDAs minutes are the official records of meetings, the FDAs documentation of 
664  meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this 
 
12 See https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm. 
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665  information is preserved for meeting attendees and future reference.  The FDA will issue the 
666  official, finalized minutes to the requester within 30 calendar days after the meeting. 
667   
668  The following are general considerations regarding meeting minutes: 
669   
670    FDA minutes will outline the important agreements, disagreements, issues for further 
671  discussion, and action items from the meeting in bulleted format.  The minutes should be 
672  sufficiently detailed that they provide clarity about the agreements, such as on study 
673  design elements, or statistical testing, or enrollment criteria and similar important areas of 
674  the development program.  The minutes are not intended to represent a transcript of the 
675  meeting. 
676   
677    FDA project managers will use established templates to ensure that all important meeting 
678  information is captured. 
679   
680    The FDA may communicate additional information in the final minutes that was not 
681  explicitly communicated during the meeting (e.g., pediatric requirements, data standards, 
682  abuse liability potential) or that provides further explanation of discussion topics.  The 
683  FDAs final minutes will distinguish this additional information from the discussion that 
684  occurred during the meeting. 
685   
686    For INTERACT meetings, preliminary responses will be annotated and resent within 30 
687  days if advice provided changes as a result of the meeting. 
688   
689    In cases of a WRO, the WRO will serve as meeting minutes. 
690   
691  The following steps should be taken when there is a difference of understanding regarding the 
692  minutes: 
693   
694    Requesters should contact the FDA project manager if there is a significant difference in 
695  their and the FDAs understanding of the content of the final meeting minutes issued to 
696  the requesters 
697   
698    If after contacting the FDA project manager there are still significant differences in the 
699  understanding of the content, the requester should submit a description of the specific 
700  disagreements either: 
701   
702    To the application; or 
703   
704    If there is no application, in a letter to the division director, with a copy to the FDA 
705  project manager 
706   
707    The review division and the office director, if the office director was present at the 
708  meeting, will take the concerns under consideration 
709   
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710    If the minutes are deemed to accurately and sufficiently reflect the meeting 
711  discussion, the FDA project manager will convey this decision to the requester and 
712  the minutes will stand as the official documentation of the meeting. 
713   
714    If the FDA deems it necessary, changes will be documented in an addendum to the 
715  official minutes.  The addendum will also document any remaining requester 
716  objections, if any.  
717   
718  For input on additional issues that were not addressed at the meeting, the requester should submit 
719  a new meeting request, a WRO request, or a submission containing specific questions for FDA 
720  feedback. 
721   
722  For all meeting types, to ensure the sponsors understanding of FDA feedback from meeting 
723  discussions or a WRO, sponsors may submit a follow-up opportunity/clarifying questions 
724  correspondence to the agency in a formal submission to their application.  Only questions of a 
725  clarifying nature should be submitted (i.e., to confirm something in minutes or in a WRO issued 
726  by the FDA) rather than new issues or new proposals.  If the FDA determines that the requests 
727  are not in scope (i.e., are not simply clarifications of advice provided at the meeting), the division 
728  may advise the sponsor to request a new meeting to address the issue.  However, if the out-of-
729  scope issue is narrow and focused, the review division, at their discretion, may provide a 
730  response (as a general correspondence) as soon as reasonably possible.  The clarifying questions 
731  should be sent in writing as a Request for Clarification to the FDA within 20 calendar days 
732  following receipt of the meeting minutes or WRO, to include if the preliminary comments serve 
733  as the final minutes for a cancelled meeting.  For questions that meet the criteria, the FDA will 
734  issue a response in writing within 20 calendar days of receipt of the clarifying questions.  The 
735  FDAs response will reference the original minutes or WRO. 
736   
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737  REFERENCES 
738   
739  Related Guidances13 
740   
741  Guidance for industry and review staff Best Practices for Communication Between IND 
742  Sponsors and FDA During Drug Development (December 2017) 
743   
744  Guidance for review staff and industry Good Review Management Principles and Practices for 
745  PDUFA Products (April 2005) 
746   
747  Related CDER MAPP14 
748   
749  MAPP 6025.6 Good Review Practice:  Management of Breakthrough Therapy-Designated 
750  Drugs and Biologics 
751   
752  Related CBER SOPPs15 
753   
754  SOPP 8101.1 Regulatory Meetings With Sponsors and Applicants for Drugs and Biological 
755  Products  
756   
757  SOPP 8404.1 Procedures for Filing an Application When the Applicant Protests a Refusal to 
758  File Action (File Over Protest) 
759   
 
13 Guidances can be found on the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
 
14 MAPPs can be found on the CDER Manual of Policies and Procedures web page at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProc
edures/default.htm. 
 
15 SOPPs can be found on the Biologics Procedures (SOPPs) web page at 
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/defau
lt.htm.  
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760  APPENDIX:  
761  SUMMARY OF MEETING MANAGEMENT PROCEDURAL GOALS 
762   
763  Table A is a summary of Prescription Drug User Fee Act meeting management procedural goals.   
764   
765  Table A.  Meeting Management Procedural Goals   
Meeting  FDA  FDA  FDA  Requester  FDA  FDA 
Type  Response  Receipt of  Preliminary  Response to  Scheduled  Meeting 
to  Meeting  Responses to  FDA  Meeting  Minutes to 
Request  Package   Requester (if  Preliminary  Date (days  Requester 
applicable)  Responses (if  from receipt  (if 
applicable)  of request)  applicable) 
A  14 days  With  No later than    Within 30  30 days after 
meeting  2 days before  --  days  meeting 
request  meeting 
B  21 days  No later  No later than    Within 60  30 days after 
than 30  2 days before  --  days  meeting 
days before  meeting 
meeting  
B  14 days  No later  No later than  No later than 3  Within 70  30 days after 
(EOP)*  than 50  5 days before  days after  days  meeting 
days before  meeting  receipt of 
meeting**  preliminary 
responses 
C  21 days  No later  No later than  No later than 3  Within 75  30 days after 
than 47  5 days before  days after  days  meeting 
days before  meeting  receipt of 
meeting***  preliminary 
responses 
D  14 days  With  No later than  No later than 3  Within 50  30 days after 
meeting  5 days before  days after  days  meeting  
request  meeting  receipt of 
preliminary 
responses 
INTERA 21 days  With  No later than  No later than 3  Within 75  Preliminary 
CT  meeting  5 days before  days after  days  responses 
request  the meeting   receipt of  annotated 30 
preliminary  days after 
responses   meeting  
766   Not applicable to written response only. 
767  * EOP = end of phase. 
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768  ** If the scheduled date of a Type B (EOP) meeting is earlier than 70 days from FDA receipt of the meeting request, 
769  the requesters meeting package will be due no sooner than 6 calendar days after FDA response time for issuing the 
770  letter granting the meeting (see Table 1 in section VI.B., Meeting Granted). 
771  *** If the scheduled date of a Type C meeting is earlier than 75 days from FDA receipt of the meeting request, the 
772  meeting package will be due no sooner than 7 calendar days after FDA response time for issuing the letter granting 
773  the meeting (see Table 1 in section VI.B., Meeting Granted).  For Type C meetings that are requested as early 
774  consultations on the use of a new surrogate endpoint to be used as the primary basis for product approval in a 
775  proposed context of use, the meeting package is due at the time of the meeting request. 
21