Formal Meetings 
Between the FDA and 
Sponsors or Applicants 
of BsUFA 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DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only.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 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publication in the Federal Register of the notice announcing the availability of the draft 
guidance.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) Sandra Benton at 301-796-1042, or 
(CBER) 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) 
 
August 2023 
Procedural 
Revision 1 
    
Formal Meetings 
Between the FDA and 
Sponsors or Applicants 
of BsUFA 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) 
 
 
August 2023 
Procedural 
Revision 1
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  MEETING TYPES ........................................................................................................... 3 
A.  BIA Meeting ................................................................................................................................... 3 
B.  BPD Type 1 Meeting ...................................................................................................................... 4 
C.  BPD Type 2a Meeting .................................................................................................................... 5 
D.  BPD Type 2b Meeting .................................................................................................................... 5 
E.  BPD Type 3 Meeting ...................................................................................................................... 5 
F.  BPD Type 4 Meeting ...................................................................................................................... 6 
IV.  BsUFA FEES ASSOCIATED WITH THE BPD PROGRAM ..................................... 6 
V.  MEETING FORMATS .................................................................................................... 7 
VI.  MEETING REQUESTS ................................................................................................... 7 
VII.  ASSESSING AND RESPONDING TO MEETING REQUESTS .............................. 10 
A.  Meeting Denied ............................................................................................................................ 11 
B.  Meeting Granted .......................................................................................................................... 11 
VIII.  MEETING PACKAGE .................................................................................................. 12 
A.  Timing of Meeting Package Submission .................................................................................... 12 
B.  Where and How Many Copies of Meeting Packages to Send .................................................. 13 
C.  Meeting Package Content ............................................................................................................ 13 
IX.  PRELIMINARY RESPONSES ..................................................................................... 15 
X.  RESCHEDULING MEETINGS.................................................................................... 15 
XI.  CANCELING MEETINGS ........................................................................................... 16 
XII.  MEETING CONDUCT .................................................................................................. 17 
XIII.  MEETING MINUTES.................................................................................................... 17 
REFERENCES ............................................................................................................................ 20 
 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Formal Meetings Between the FDA  
2  and Sponsors or Applicants of BsUFA Products 
3  Guidance for Industry1 
4   
5   
6   
7   
8  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
9  Administration (FDA or Agency) on this topic.  It does not establish any rights for any person and is not 
10  binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
11  applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
12  for this guidance as listed on the title page. 
13   
14   
15   
16   
17  I.  INTRODUCTION 
18   
19  This guidance provides recommendations to industry on formal meetings between the Food and 
20  Drug Administration (FDA) and sponsors or applicants relating to the development and review 
21  of biosimilar or interchangeable biosimilar products2 regulated by the Center for Drug 
22  Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).   
23   
24  This guidance does not apply to meetings associated with the development of products intended 
25  for submission in, or with the review of, new drug applications or abbreviated new drug 
26  applications under section 505 of the Federal Food, Drug and Cosmetic Act (FD&C Act), 
27  biologics license applications (BLAs) under section 351(a) of the Public Health Service Act 
28  (PHS Act),3 or submissions for devices under the FD&C Act.4  For the purposes of this 
29  guidance, formal meeting includes any meeting that is requested by a sponsor or applicant 
30  (hereafter referred to as requester(s)) following the procedures provided in this guidance and 
 
1 This guidance has been prepared by the Center for Drug Evaluation and Research in cooperation with the Center 
for Biologics Evaluation and Research at the Food and Drug Administration.  
 
2 In this guidance, the following terms are used to describe biological products licensed under section 351(k) of the 
PHS Act: (1) biosimilar or biosimilar product refers to a product that FDA has determined to be biosimilar to 
the reference product (see sections 351(i)(2) and 351(k)(2) of the PHS Act) and (2) interchangeable biosimilar or 
interchangeable product refers to a biosimilar product that FDA has determined to be interchangeable with the 
reference product (see sections 351(i)(3) and 351(k)(4) of the PHS Act). 
 
3 For information on meetings for new drug applications and 351(a) BLAs, see the draft guidance for industry 
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (December 2017).  When final, 
this guidance will represent the FDAs current thinking on this topic.  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. 
 
4 For information on meetings for medical device submissions, see the guidance for industry Requests for Feedback 
and Meetings for Medical Device Submissions: The Q-Submission Program (June 2023). 
1  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
31  includes meetings conducted in any format (i.e., in-person, virtual (videoconference), 
32  teleconference, or written response only (WRO)). 
33   
34  This guidance discusses the principles of good meeting management practices (GMMPs) and 
35  describes standardized procedures for requesting, preparing, scheduling, conducting, and 
36  documenting such formal meetings.5  
37   
38  This draft guidance for industry revises and replaces the draft guidance of the same name issued 
39  in June 2018.  This revision includes:  
40   
41    Changes to the data expectations in Biosimilar Initial Advisory (BIA) meeting requests 
42   
43    Addition of Biological Product Development (BPD) Type 2a meeting 
44   
45    Changes to when the meeting background package is submitted for BPD Type 4 meeting 
46   
47    Changes to the description of the available meeting formats 
48   
49    Addition of an option for a request for clarification  
50   
51  FDA also made certain clarifying and editorial changes. Editorial changes were made primarily 
52  for clarification. 
53   
54  In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
55  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
56  as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
57  the word should in Agency guidances means that something is suggested or recommended, but 
58  not required. 
59   
60   
61  II.  BACKGROUND 
62   
63  Each year, FDA review staff participate in many meetings with requesters who seek advice 
64  relating to the development and review of a biosimilar or interchangeable biosimilar product.  
65  Because these meetings often represent critical points in the regulatory and development process, 
66  it is important that there are efficient, consistent procedures for the timely and effective conduct 
67  of such meetings.  The GMMPs in this guidance are intended to provide consistent procedures 
68  that will promote well-managed meetings and to ensure that such meetings are scheduled within 
69  a reasonable time, conducted efficiently, and documented appropriately. 
70   
 
5 The previous guidance for industry Formal Meetings Between the FDA and Biosimilar Biological Product 
Sponsors or Applicants published November 18, 2015, has been withdrawn. 
 
2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
71  As part of the reauthorization of the Biosimilar User Fee Act (BsUFA), the FDA has committed 
72  to specific performance goals that include meeting management goals for formal meetings that 
73  occur between the FDA and requesters.6  
74   
75   
76  III.  MEETING TYPES7 
77   
78  There are six types of formal meetings that occur between requesters and FDA staff to discuss 
79  development and review of a biosimilar or interchangeable biosimilar product:  BIA, BPD Type 
80  1, BPD Type 2a, BPD Type 2b, BPD Type 3, and BPD Type 4.  
81   
82  A.  BIA Meeting 
83   
84  A BIA meeting is an initial assessment limited to a general discussion regarding whether 
85  licensure under section 351(k) of the PHS Act may be feasible for a particular product, and if so, 
86  general advice on the expected content of the development program as it relates to the 
87  biosimilarity assessment.  This meeting type does not involve substantive review of summary 
88  data or full study reports.  Although the FDA encourages requesters to provide analytical data 
89  from at least one lot of the proposed biosimilar or interchangeable biosimilar product compared 
90  to the U.S.-licensed reference product, the data are not required as long as the requester provides 
91  sufficient information with the meeting request to enable the FDA to make a preliminary 
92  determination as to whether licensure under section 351(k) of the PHS Act may be feasible for a 
93  particular product and to provide meaningful advice.  The meeting request should include the 
94  following, as appropriate: 
95   
96    Identification of reference product.   
97   
98    The indications intended to be sought for licensure. 
99   
100    A comparative analytical assessment plan, including preliminary identification of the 
101  critical quality attributes and planned characterization methods.   
102   
103    If a requester seeks to use a non-U.S.-licensed comparator product during development, 
104  the proposed bridging strategy to justify the relevance of the data generated with the non-
105  U.S.-licensed comparator product.   
106   
107    A conceptual plan for nonclinical studies or rationale and justification for why such 
108  studies may not be needed.   
109   
 
6 See BsUFA III goals letter titled Biosimilar Biological Product Reauthorization Performance Goals and 
Procedures Fiscal Years 2023 Through 2027 available on the FDA website at 
https://www.fda.gov/media/152279/download. 
 
7 The meeting types and goal dates are described in the BsUFA III goals letter and apply to formal meetings between 
FDA staff and requesters of BsUFA meetings; they do not apply to meetings with CDER Office of Generic Drugs, 
CDER Office of Compliance, or CDER Office of Prescription Drug Promotion.  
3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
110    A conceptual description of the planned clinical pharmacokinetics and/or 
111  pharmacodynamic study or studies, including proposed endpoints.   
112   
113    A conceptual plan that includes initial considerations regarding the need for a 
114  comparative clinical study. If the requester plans to conduct a comparative clinical safety 
115  and efficacy study, this conceptual plan should include the patient population and 
116  proposed endpoints.   
117   
118    Any guidance already received from other health authorities on product development. 
119   
120    Identification to the FDA of the regulatory status in other jurisdictions. 
121   
122  Extensive analytical, nonclinical, and/or clinical data are not expected to be provided based on 
123  the expected stage of development of the proposed biosimilar or interchangeable biosimilar 
124  product.  If the requester is seeking targeted advice on the adequacy of any comparative data or 
125  extensive advice for any aspect of a planned or ongoing biosimilar or interchangeable biosimilar 
126  product development program, a different meeting type should be requested. 
127   
128  B.  BPD Type 1 Meeting 
129   
130  A BPD Type 1 meeting is a meeting that is necessary for an otherwise stalled development 
131  program to proceed or a meeting to address an important safety issue.  Examples of a BPD Type 
132  1 meeting include the following: 
133   
134    Meetings to discuss clinical holds in which (1) the requester seeks input on how to 
135  address the hold issues; or (2) a response to hold issues has been submitted and reviewed 
136  by the FDA, but the FDA and the requester agree that the development is stalled and a 
137  new path forward should be discussed. 
138   
139    Meetings that are requested after receipt of an FDA nonagreement special protocol 
140  assessment letter in response to protocols submitted under the special protocol 
141  assessment procedures as described in the guidance for industry Special Protocol 
142  Assessment (April 2018). 
143   
144    Meetings to discuss an important safety issue, when such an issue is identified and the 
145  FDA and requester agree that the issue should be discussed.  
146   
147    Dispute resolution meetings as described in 21 CFR 10.75 and 312.48 and in the 
148  guidance for industry and review staff Formal Dispute Resolution:  Sponsor Appeals 
149  Above the Division Level (May 2019). 
150   
151    Post-action meetings requested after an FDA regulatory action other than an approval 
152  (i.e., issuance of a complete response letter). 
153   
154    Meetings requested within 30 days of FDA issuance of a refuse-to-file letter to discuss 
155  whether the FDA should file the application. 
4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
156   
157  C.  BPD Type 2a Meeting 
158   
159  A BPD Type 2a meeting is a meeting focused on a narrow set of issues (e.g., often one, but not 
160  more than two issues and associated questions), requiring input from no more than three 
161  disciplines or review divisions.  To request a BPD Type 2a meeting, requesters must first have 
162  had a BIA or another BPD meeting type with the FDA.8  Examples of such discussion issues 
163  could include the following: 
164   
165    Immunogenicity testing strategy following prior FDA recommendations or feedback. 
166   
167    A request for feedback on an updated study design when the revisions are based on prior 
168  FDA feedback. 
169   
170    Defined chemistry, manufacturing, and controls (CMC) postapproval commitments (e.g., 
171  related to analytical methods) discussing the approach in advance of conducting the study 
172  to ensure the approach is in line with the FDAs expectations.  
173   
174  D.  BPD Type 2b Meeting 
175   
176  A BPD Type 2b9 meeting is a meeting to discuss a specific issue (e.g., ranking of quality 
177  attributes; CMC such as control strategy; study design or endpoints; postapproval changes) or 
178  questions for which the FDA will provide targeted advice regarding an ongoing development 
179  program.  This meeting type may include substantive review of summary data but does not 
180  include review of full study reports. 
181   
182  E.  BPD Type 3 Meeting 
183   
184  A BPD Type 3 meeting is an in-depth data review and advice meeting regarding an ongoing 
185  development program.  This meeting type includes substantive review of full study reports (e.g., 
186  detailed and robust analytical similarity data or clinical study reports), FDA advice regarding 
187  similarity between the proposed biosimilar or interchangeable biosimilar product and the 
188  reference product, and FDA advice regarding the need for additional studies, including design 
189  and analysis. 
190   
191    Examples of a BPD Type 3 meeting submission include the following: 
192   
193   Comprehensive analytical similarity data sufficient for the FDA to make a 
194  preliminary evaluation of analytical similarity.  The level of analytical data provided 
 
8 Section I.H. of the BsUFA III goals letter. 
 
9 A BPD Type 2b meeting under BsUFA III has the same scope as a BPD Type 2 meeting under BsUFA II; 
accordingly, FDA considers a BPD Type 2b meeting to be broader in scope than a BPD Type 2a meeting. 
5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
195  should be similar to what the requester intends to submit in a 351(k) BLA (e.g., full 
196  study reports and/or datasets that support the full study reports).  
197   
198   Full study report(s) for a clinical study or studies. 
199   
200    Based on the data and/or datasets and results reported in the full study reports, the FDA 
201  encourages the requester to provide an update on the development plan of the proposed 
202  biosimilar or interchangeable biosimilar product.  Examples of topics the requester can 
203  address as part of a BPD Type 3 meeting in addition to the in-depth data submitted 
204  include the following: 
205   
206   Proposal for any additional planned studies 
207   
208   Proposal for justification of extrapolation 
209   
210  F.  BPD Type 4 Meeting 
211   
212  A BPD Type 4 meeting is a presubmission meeting to discuss the format and content of a 
213  complete original application under the Program for Enhanced Review Transparency and 
214  Communication for Original 351(k) BLAs (also known as the Program)10 or supplement 
215  submitted under 351(k) of the PHS Act for a biosimilar or interchangeable biosimilar product.  
216  The purpose of this meeting is to discuss the format and content of the planned submission and 
217  other items, including the following: 
218   
219    Identification of those studies that the requester is relying on to support a demonstration 
220  of biosimilarity or interchangeability 
221   
222    Discussion of any potential review issues identified based on the information provided 
223   
224    Identification of the status of pediatric assessments or investigations to adequately 
225  address the Pediatric Research Equity Act  
226   
227    Acquainting FDA reviewers with the general information to be submitted in the 
228  marketing application (including technical information) 
229   
230    Discussion of the best approach to the presentation and formatting of data in the 
231  marketing application 
232   
233   
234  IV.  BsUFA FEES ASSOCIATED WITH THE BPD PROGRAM 
235   
236  Under the BsUFA user fee provisions of the FD&C Act, BPD fees are assessed for products in 
237  the BPD program.  BPD fees include the initial BPD fee, the annual BPD fee, and the 
238  reactivation fee.  No fee is associated with a BIA meeting.  For more information about BsUFA 
 
10 See BsUFA III goals letter. 
6  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
239  fees, including the assessment of BPD fees and the consequences for failure to pay any required 
240  BPD fees, refer to the guidance for industry Assessing User Fees Under the Biosimilar User Fee 
241  Amendments of 2022 (July 2023).  
242   
243   
244  V.  MEETING FORMATS 
245   
246  There are four meeting formats: in-person, virtual (videoconference), teleconference, and WRO 
247  as follows: 
248   
249  1.  Face-to-Face: 
250   
251  a.  In-person: The majority of attendees participate in person at the FDA. 
252   
253  b.  Virtual (videoconference): Attendees participate from various remote locations via a 
254  video and audio connection (e.g., with cameras on and screen sharing). 
255   
256  2.  Teleconference:  Attendees participate from various remote locations via an audio only 
257  connection (e.g., telephone). 
258   
259  3.  Written response only (WRO):  WRO responses are sent to requesters in lieu of 
260  meetings conducted in one of the three formats described above.  Requesters may request 
261  this meeting format for BIA, BPD Type 2a, and BPD Type 2b meetings. 
262   
263   
264  VI.  MEETING REQUESTS 
265   
266  To make the most efficient use of FDA resources, before seeking a meeting, requesters should 
267  consult the information publicly available from the FDA that relates to biosimilar or 
268  interchangeable biosimilar product development.11   
269   
270  To promote efficient meeting management, requesters should anticipate future needs and, to the 
271  extent practical, combine related product development issues into the fewest possible meetings. 
272   
273  To request a meeting, submit a written request to the FDA via the respective centers document 
274  room (paper submissions) or via the electronic gateway, as appropriate.  Written meeting 
275  requests must be made in accordance with any applicable electronic submission requirements.12  
276  Meeting requests must be addressed to the appropriate review division or office to qualify for 
 
11 See the guidance for industry and review staff Best Practices for Communication Between IND Sponsors and 
FDA During Drug Development (December 2017). 
 
12 See the guidances for industry Providing Regulatory Submissions in Electronic Format  Submissions Under 
Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (December 2014) and Providing Regulatory 
Submissions in Electronic Format  Certain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications (February 2020).   
 
7  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
277  meeting management performance goals,13 and if previously assigned, are expected to be 
278  submitted to the pre-investigational new drug application (pre-IND) file or application (e.g., 
279  investigational new drug application (IND), BLA).  The FDA considers meeting requests sent by 
280  fax or email to be courtesy copies only and are not substitutes for formal submissions. 
281   
282  The requester should submit a meeting request for the development of a proposed biosimilar or 
283  interchangeable biosimilar product with multiple indications that span multiple review divisions 
284  to the division that has regulatory oversight of the reference product. 
285   
286  Requesters are not required to request meetings in sequential order (e.g., BIA, BPD Type 2a, 
287  BPD Type 2b, BPD Type 3, then BPD Type 4).  However, to request a Type 2a meeting, 
288  requesters must first have had a BIA or another BPD meeting type with FDA.14  The meeting 
289  type requested depends on the stage of the development program and/or the advice sought.  The 
290  FDA will grant one BIA meeting for the development program of a particular biosimilar or 
291  interchangeable biosimilar product and, generally, one BPD Type 4 meeting for each application 
292  or supplement, as appropriate.  The FDA will, as appropriate, grant as many BPD Type 2a, BPD 
293  Type 2b, and BPD Type 3 meetings as are requested and considered necessary to support the 
294  development and review of a biosimilar or interchangeable biosimilar product. 
295   
296  The meeting request should include adequate information for the FDA to assess the potential 
297  utility of the meeting and to identify FDA staff necessary to discuss proposed agenda items.   
298   
299  The meeting request should include the following information: 
300   
301  1.  Application number (if previously assigned). 
302   
303  2.  Development-phase code name of product (if pre-licensure). 
304   
305  3.  Proper name (if post-licensure). 
306   
307  4.  Structure (if applicable). 
308   
309  5.  Proper and proprietary names of the reference product.  
310   
311  6.  Proposed indication(s) or context of product development. 
312   
313  7.  Pediatric study plans (if applicable). 
314   
315  8.  Human factors engineering plan (if applicable). 
316   
317  9.  Combination product information (e.g., constituent parts, including details of the device 
318  constituent part, intended packaging, planned human factors studies) (if applicable).  
319   
 
13 BsUFA III goals letter. 
 
14 BsUFA III goals letter. 
8  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
320  The meeting request must include the following information for the performance goals 
321  (described in section I.H., Meeting Management Goals, of the BsUFA III goals letter) to apply:  
322   
323  1.  Meeting type being requested (i.e., BIA meeting, BPD Type 1, Type 2a, Type 2b, Type 3, 
324  or Type 4 meeting).  The rationale for requesting the meeting type should also be 
325  included.  
326   
327  2.  Proposed meeting format (i.e., in-person, virtual (videoconference), teleconference, or 
328  WRO). 
329   
330  3.  Brief statement of the purpose of the meeting.  This statement should include a brief 
331  background of the issues underlying the proposed agenda.  It also can include a brief 
332  summary of completed or planned studies or data that the requester intends to discuss at 
333  the meeting, the general nature of the critical questions to be asked, and where the 
334  meeting fits in overall development plans.  Although the statement should not provide the 
335  details of study designs or completed studies, it should provide enough information to 
336  facilitate understanding of the issues, such as a small table that summarizes major results. 
337   
338  4.  List of specific objectives or outcomes the requester expects from the meeting. 
339   
340  5.  Proposed agenda, including estimated times needed for discussion of each agenda item. 
341   
342  6.  List of questions, grouped by FDA discipline.  For each question there should be a brief 
343  explanation of the context and purpose of the question. 
344   
345  7.  List of planned attendees from the requesters organization, which should include their 
346  names and titles.  The list should also include names, titles, and affiliations of consultants 
347  and interpreters (if applicable). 
348   
349  8.  List of requested FDA attendees and/or discipline representative(s).  Requests for 
350  attendance by FDA staff who are not otherwise essential to the applications review may 
351  affect the ability to hold the meeting within the specified time frame of the meeting type 
352  being requested.  Therefore, when attendance by nonessential FDA staff is requested, the 
353  meeting request should provide a justification for such attendees and state whether a later 
354  meeting date is acceptable to the requester to accommodate the inclusion of nonessential 
355  FDA attendees. 
356   
357  9.  Suggested dates and times (e.g., morning, afternoon) for the meeting that are within or 
358  beyond the appropriate scheduling time frame of the meeting type being requested (see 
359  Table 2 in section VII.B., Meeting Granted).  Dates and times when the requester is not 
360  available should also be included. 
361   
362  When submitting a meeting request, the requester should define the specific areas of input 
363  needed from the FDA.  A well-written meeting request that includes the above components can 
364  help the FDA understand and assess the utility and timing of the meeting related to product 
365  development or review.  The list of planned attendees and the list of requested FDA attendees 
9  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
366  can be useful in providing or preparing for the input needed at the meeting.  However, during the 
367  time between the request and the meeting, the planned attendees can change.  If there are 
368  changes, an updated list of attendees with their titles and affiliations should be provided to the 
369  appropriate FDA contact at least 1 week before the meeting.  
370   
371  The objectives and agenda provide overall context for the meeting topics, but it is the list of 
372  questions that is most critical to understanding the kind of information or input needed by the 
373  requester and to focus the discussion should the meeting be granted.  Each question should be 
374  precise and include a brief explanation of the context and purpose of the question.  The questions 
375  submitted within a single meeting request should be limited to those that can be reasonably 
376  answered within the allotted meeting time, taking into consideration the complexity of the 
377  questions submitted.  Similar considerations regarding the complexity of questions submitted 
378  within a WRO should be applied.  
379   
380   
381  VII.  ASSESSING AND RESPONDING TO MEETING REQUESTS 
382   
383  Although requesters must request a specific meeting type and format,15 the FDA assesses each 
384  meeting request, including WRO requests for BIA, BPD Type 2a, and BPD Type 2b meetings, 
385  and determines whether or not the request should be granted, the appropriate meeting type, and 
386  the appropriate meeting format.  The FDA honors requests for BPD Type 2b, BPD Type 3, and 
387  BPD Type 4 meetings except in the most unusual circumstances.  However, the FDA may 
388  determine that a different type of meeting is more appropriate and may grant a different type of 
389  meeting than is requested.16  Additionally, if the FDA determines that the WRO format is not 
390  appropriate for a requested WRO meeting or that the face-to-face (i.e., in-person, virtual 
391  (videoconference)) or teleconference format is not appropriate for a requested face-to-face or 
392  teleconference meeting, the FDA will notify the requester that the meeting has been denied, as 
393  described in section VII.A., Meeting Denied.  However, if an in-person, virtual 
394  (videoconference) or teleconference meeting format is requested for a BPD Type 2a meeting, but 
395  the FDA determines that a written response to the questions would be the most appropriate 
396  format, the FDA will notify the requester as described in section VII.B. Meeting Granted.  
397   
398  The meeting request must be accompanied by the meeting package for BIA, BPD Type 1, BPD 
399  Type 2a, BPD Type 2b, and BPD Type 3 meetings (see section VIII.C., Meeting Package 
400  Content, for additional information regarding the content of the meeting package).17  This 
401  ensures that the FDA has adequate information to assess the potential utility of the meeting and 
402  prepare for the meeting.  If the meeting package is not submitted to the review division as 
403  described above, the FDA will consider the meeting request incomplete and will generally deny 
404  the meeting request.   
 
15 BsUFA III goals letter. 
 
16 If FDA grants a meeting of a different type than requested, this may require the payment of a biosimilar biological 
product development fee as described in section 744H of the FD&C Act before the meeting will be conducted.   If a 
biosimilar biological product development fee is required under section 744H, and the sponsor does not pay the fee 
within the timeframe required under section 744H, the meeting will be cancelled.   
 
17 BsUFA III goals letter. 
10  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
405   
406  A.  Meeting Denied 
407   
408  If a meeting request is denied, the FDA will notify the requester in writing according to the 
409  timelines described in Table 1.  These notifications include an explanation of the reason for the 
410  denial.  Denials are based on substantive reason, not merely on the absence of a minor element of 
411  the meeting request or a minor element of the meeting package.  For example, the FDA may 
412  deny a meeting request because it is premature for the stage of product development, is clearly 
413  unnecessary, or is not appropriate for the format requested (e.g., WRO versus in-person/virtual 
414  (videoconference)/teleconference for BIA, BPD Type 2a, or BPD Type 2b meetings) or the 
415  meeting package does not provide an adequate basis for the meeting discussion.   
416   
417  The FDA may also deny requests for meetings that do not have substantive information related 
418  to the elements described in section VI., Meeting Requests.  FDA will consider a subsequent 
419  request to schedule the meeting as a new request (i.e., a request that is assigned a new set of time 
420  frames described below in section VII.B., Meeting Granted). 
421   
422  B.  Meeting Granted 
423   
424  If a meeting request is granted, the FDA will notify the requester in writing according to the 
425  timelines described in Table 1.  For in-person, teleconference, virtual (videoconference) 
426  meetings, these notifications include the date, time, conferencing arrangements and/or location of 
427  the meeting, and expected FDA participants.  For BIA, BPD Type 2a, and BPD Type 2b WRO 
428  meetings, these notifications include the date the FDA intends to send the written response (see 
429  Table 3 for FDA WRO response timelines). 
430   
431  For the BPD Type 2a meeting, although the requester may request an in-person, virtual 
432  (videoconference), or teleconference format, the FDA may determine that a written response to 
433  the requesters questions would be the most appropriate means for providing feedback and 
434  advice to the requester.  When it is determined that the meeting request can be appropriately 
435  addressed through a written response, the FDA will notify the requester of the meeting format 
436  change in writing and this notification will include the date the FDA intends to send the written 
437  response in the Agencys response to the meeting request (see Table 3 for FDA WRO response 
438  timelines).  If the requester believes an in-person, virtual (videoconference), or teleconference 
439  BPD Type 2a meeting is valuable and warranted, then the requester may provide rationale in a 
440  follow-up correspondence explaining why that meeting format is valuable and warranted, and the 
441  FDA will reconsider this request.  If the FDA agrees to grant the in-person, virtual 
442  (videoconference), or teleconference format, the Agency will strive to schedule the meeting to 
443  occur within 60 days of FDAs receipt of the meeting request. 
444   
445  For in-person, virtual (videoconference), or teleconference meeting formats, the FDA schedules 
446  the meeting on the next available date at which all expected FDA staff are available to attend.  
447  However, the meeting should be scheduled consistent with the type of meeting requested (see 
448  Table 2 for FDA meeting scheduling time frames).  If the requested date for any meeting type is 
449  greater than the specified time frame, the meeting date should be within 14 calendar days of the 
450  requested date.   
11  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
451  Table 1:  FDA Meeting Request Response Timelines 
Response Time  
Meeting Type 
(calendar days from receipt of meeting 
 
request) 
BIA  21 days 
BPD 1  14 days 
BPD 2a  21 days 
BPD 2b  21 days 
BPD 3  21 days 
BPD 4  21 days 
452   
453  Table 2:  FDA Meeting Scheduling Time Frames 
Meeting Scheduling  
Meeting Type  (calendar days from receipt of 
meeting request) 
BIA  75 days  
BPD 1  30 days  
BPD 2a  60 days  
BPD 2b  90 days  
BPD 3  120 days  
BPD 4  60 days 
454   
455  Table 3:  FDA WRO Response Timelines 
WRO Response Time  
Meeting Type  (calendar days from receipt of  
WRO meeting request) 
BIA  75 days 
BPD 2a  60 days  
BPD 2b  90 days 
456   
457   
458  VIII.  MEETING PACKAGE 
459   
460  Premeeting preparation is critical for achieving a productive discussion or exchange of 
461  information.  Preparing the meeting background package should help the requester focus on 
462  describing its principal areas of interest.  The meeting package should provide information 
463  relevant to the discussion topics and enable the FDA to prepare adequately for the meeting.   
464   
465  A.  Timing of Meeting Package Submission 
466   
467  As discussed in section VII., Assessing and Responding to Meeting Requests, if the meeting 
468  package is not submitted with the meeting request for BIA, BPD Type 1, BPD Type 2a, BPD 
469  Type 2b, and BPD Type 3 meetings, the meeting request is considered incomplete and the FDA 
12  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
470  generally will deny the meeting.  For BPD Type 4 meetings, the background package must be 
471  received no later than 14 calendar days after the FDAs receipt of the meeting request.18 
472   
473  B.  Where and How Many Copies of Meeting Packages to Send 
474   
475  Requesters must submit a meeting package to the appropriate review division or office19 and, if 
476  previously assigned, is expected to be submitted to the relevant pre-IND file or application(s) 
477  (e.g., IND, BLA).  Meeting packages are expected to be submitted via the appropriate centers 
478  document room (paper submission) or electronic gateway, as applicable.  Submissions must be 
479  made in accordance with any applicable electronic submission requirements.20   
480   
481  Occasionally, to facilitate the meeting process, CDER staff may request, in addition to the 
482  electronic format, a limited number of meeting packages in paper format (desk copies).  The 
483  number of desk copies of a meeting package will vary based on the meeting.  The CDER project 
484  manager will advise on the number of desk copies needed for the meeting attendees.  CBER 
485  neither requests nor accepts paper copies (desk copies) of meeting packages that have been 
486  submitted in electronic format. 
487   
488  C.  Meeting Package Content 
489   
490  The meeting package should provide information relevant to the product, stage of development, 
491  and meeting type requested (see section III., Meeting Types), in addition to any supplementary 
492  information needed to develop responses to issues raised by the requester or review division.  
493  The meeting package should contain sufficient details to meet the intended meeting objectives.  
494  For example, inclusion of raw data in addition to the derived conclusions may be appropriate in 
495  some situations.  Similarly, merely describing a result as significant does not provide the review 
496  division with enough information to give advice or identify important problems the requester 
497  may have missed.  FDA guidances identify and address many issues related to biosimilar or 
498  interchangeable biosimilar product development, and requestors should consider these when 
499  planning, developing, and providing information needed to support a meeting with the FDA.21  If 
500  a product development plan adopts an alternative approach from that recommended in FDA 
501  guidance, the alternative approach should be recognized and explained.  Known or expected 
502  difficult design and evidence issues should be raised for discussion (e.g., selection of study 
503  populations, doses, or endpoints different from those studied for the reference products 
504  licensure; extrapolation of data and information). 
505   
 
18 BsUFA III goals letter. 
 
19 Id. 
 
20 See the guidances for industry Providing Regulatory Submissions in Electronic Format  Submissions Under 
Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (December 2014) and Providing Regulatory 
Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related Submissions 
Using the eCTD Specifications (February 2020).   
 
21 See the FDA Biosimilars Industry Information and Guidance web page, available at 
https://www.fda.gov/drugs/biosimilars/industry-information-and-guidance. 
13  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
506  To facilitate FDA review, the meeting package content should be organized according to the 
507  proposed agenda.  The meeting package should be a sequentially paginated document with a 
508  table of contents, appropriate indices, appendices, and cross references.  It should be tabbed or 
509  bookmarked to enhance reviewers navigation across different sections within the package, both 
510  in preparation for and during the meeting.  Meeting packages generally should include the 
511  following information in the order listed below: 
512   
513  1.  Application number (if previously assigned). 
514   
515  2.  Development-phase code name of product (if pre-licensure).  
516   
517  3.  Proper name (if post-licensure). 
518   
519  4.  Structure (if applicable). 
520   
521  5.  Proper and proprietary names of the reference product. 
522   
523  6.  Proposed indication(s) or context of product development. 
524   
525  7.  Dosage form, route of administration, dosing regimen (frequency and duration), strength, 
526  and presentation(s). 
527   
528  8.  Pediatric study plans (if applicable). 
529   
530  9.  Human factors engineering plan (if applicable). 
531   
532  10. Combination product information (e.g., constituent parts, including details of the device 
533  constituent part, intended packaging, planned human factors studies) (if applicable).  
534   
535  11. List of planned attendees, including titles and affiliations, from the requesters 
536  organization, including consultants and interpreters (if applicable). 
537   
538  12. Background section that includes the following: 
539   
540  a.  Brief history of the development program and relevant communications with the FDA 
541  before the meeting.  
542   
543  b.  Substantive changes in product development plans (e.g., manufacturing changes, new 
544  study population or endpoint) (when applicable). 
545   
546  c.  Status of product development (e.g., CMC; nonclinical; clinical, including any 
547  development outside the United States, as applicable). 
548   
549  13. Brief statement summarizing the purpose of the meeting. 
550   
551  14. Proposed agenda, including estimated times needed for discussion of each agenda item. 
14  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
552   
553  15. List of questions for discussion, grouped by FDA discipline and with a brief summary for 
554  each question to explain the need or context for the question.  Questions regarding 
555  combination product issues should be grouped together. 
556   
557  16. Data to support discussion organized by FDA discipline and question.  The level of detail 
558  of the data should be appropriate to the meeting type requested and the stage of product 
559  development. 
560   
561   
562  IX.  PRELIMINARY RESPONSES 
563   
564  Communications before the meeting between requesters and the FDA, including preliminary 
565  responses, can serve as a foundation for discussion or as the final meeting responses.  
566  Nevertheless, preliminary responses should not be construed as final unless there is agreement 
567  between the requester and the FDA that additional discussion is not necessary for any question 
568  (i.e., when the meeting is canceled because the requester is satisfied with the FDAs preliminary 
569  responses), or a particular question is considered resolved, allowing time for discussion of the 
570  other questions during the meeting.  Preliminary responses communicated by the FDA are not 
571  intended to generate the submission of new information or new questions.  If a requester 
572  nonetheless provides new data or a revised or new proposal, the FDA may not be able to provide 
573  comments on the new information, and the requester may need to submit a new meeting request 
574  for the FDA to provide feedback on the new information.  
575   
576  The FDA holds internal meetings, including meetings with relevant committees within CDER or 
577  CBER, to discuss the content of meeting packages and to gain internal alignment on the 
578  preliminary responses.  The FDA will send the requester its preliminary responses to the 
579  questions in the meeting package no later than 5 calendar days before the in-person, virtual 
580  (videoconference), or teleconference meeting date for BPD Type 2b and BPD Type 3 meetings.  
581  For all other meeting types, the FDA intends to send the requester its preliminary responses to 
582  the questions no later than 2 calendar days before the in-person, virtual (videoconference), or 
583  teleconference meeting.  
584   
585   
586  X.  RESCHEDULING MEETINGS 
587   
588  Occasionally, circumstances arise that necessitate the rescheduling of a meeting.  If a meeting 
589  needs to be rescheduled, it should be rescheduled as soon as possible after the original meeting 
590  date.  A new meeting request should not be submitted.  Requesters and the FDA should take 
591  reasonable steps to avoid rescheduling meetings.  For example, if an attendee becomes 
592  unavailable, a substitute can be identified, or comments on the topic that the attendee would have 
593  addressed can be forwarded to the requester following the meeting.  It is at the discretion of the 
594  review division whether the meeting should be rescheduled depending on the specific 
595  circumstances. 
596   
15  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
597  The following situations are examples of when the FDA may reschedule a meeting.  This list 
598  includes representative examples and is not intended to be an exhaustive list. 
599   
600    The review team determines that additional information is needed to address the 
601  requesters questions or other important issues, and it is possible to identify the additional 
602  information needed and arrange for its timely submission. 
603   
604    Essential attendees are no longer available for the scheduled date and time because of an 
605  unexpected or unavoidable conflict or an emergency situation. 
606   
607    Before preliminary responses to the questions are sent by the FDA, the requester sends 
608  the FDA additional questions or data that are intended for discussion at the meeting and 
609  require additional review time. 
610   
611    Attendance by additional FDA personnel not originally anticipated or requested is critical 
612  and their unavailability precludes holding the meeting on the original date. 
613   
614   
615  XI.  CANCELING MEETINGS 
616   
617  Failure to pay required BPD fees for a product within the required time frame may result in the 
618  cancellation by the FDA of a scheduled BPD meeting.22  For more information on BPD fees, 
619  refer to the guidance for industry Assessing User Fees Under the Biosimilar User Fee 
620  Amendments of 2022 (July 2023).  If the requester pays the required BPD fee after the meeting 
621  has been canceled because of nonpayment, the goal time frame for the FDAs response to a 
622  meeting request will be calculated from the date on which the FDA received the payment, not the 
623  date on which the requester originally submitted the meeting request.23  
624   
625  Occasionally, other circumstances arise that necessitate the cancellation of a meeting.  If a 
626  meeting is canceled for reasons other than nonpayment of a required BPD fee, the FDA 
627  considers a subsequent request to schedule a meeting to be a new request and the goal time frame 
628  for the FDAs response is calculated from the date of the subsequent request.  Requesters and the 
629  FDA should take reasonable steps to avoid canceling meetings (unless the meeting is no longer 
630  necessary).  Cancellation is at the discretion of the review division and depends on the specific 
631  circumstances. 
632   
633  The following situations are examples of when a meeting may be canceled.  This list includes 
634  representative examples and is not intended to be an exhaustive list. 
635   
636    The requester determines that preliminary responses to its questions are sufficient for its 
637  needs and additional discussion is not necessary (see section IX., Preliminary Responses).  
638  In this case, the requester should contact the FDA regulatory project manager to request 
639  cancellation of the meeting.  The FDA then considers whether it agrees that the meeting 
 
22 See section 744H(a)(1)(E)(i) of the FD&C Act. 
 
23 BsUFA III goals letter. 
16  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
640  should be canceled.  Some meetings can be valuable because of the discussion they 
641  generate and the opportunity for the division to ask about relevant matters, even if the 
642  preliminary responses to the requesters questions seem sufficient.  If the FDA agrees that 
643  the meeting can be canceled, the reason for cancellation is documented and the 
644  preliminary responses represent the final responses and the official record. 
645   
646    The FDA determines that the meeting package is inadequate or, for BPD Type 4 
647  meetings, the meeting package is not received by the FDA within 14 calendar days of the 
648  meeting request.  Meetings are scheduled on the condition that the requester has 
649  submitted appropriate information to support the discussion.  Adequate planning by the 
650  requester should avoid this problem. 
651   
652   
653  XII.  MEETING CONDUCT 
654   
655  Meetings will be chaired by an FDA staff member and begin with introductions and an overview 
656  of the agenda.  Attendees should not make audio or visual recordings of discussions at meetings 
657  described in this guidance. 
658   
659  In general, presentations by requesters are not needed because the information necessary for 
660  review and discussion should be part of the meeting package.  If a requester plans to make a 
661  presentation, the presentation should be discussed ahead of time with the FDA project manager 
662  to determine if a presentation is warranted and to ensure that the FDA has the presentation 
663  materials ahead of the meeting, if possible.  All presentations should be kept brief to maximize 
664  the time available for discussion.  The FDA will not extend the length of a meeting to 
665  accommodate a presentation.  If a presentation contains more than a small amount of content, 
666  distinct from clarifications or explanations of previous data, that was not included in the original 
667  meeting package submitted for review, FDA staff may not be able to provide commentary. 
668   
669  Either a representative of the FDA or the requester should summarize the important discussion 
670  points, agreements, clarifications, and action items.  Summation can be done at the end of the 
671  meeting or after the discussion of each question.  Generally, the requester is asked to present the 
672  summary to ensure that there is mutual understanding of meeting outcomes and action items.  
673  FDA staff can add or further clarify any important points not covered in the summary and these 
674  items can be added to the meeting minutes.   
675   
676  At BPD Type 4 meetings for original applications reviewed under the Program, the requester and 
677  the FDA should also summarize agreements regarding the content of a complete application and 
678  any agreements reached on delayed submission of certain minor application components. 
679   
680   
681  XIII.  MEETING MINUTES 
682   
683  Because the FDAs minutes are the official records of meetings, the FDAs documentation of 
684  meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this 
17  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
685  information is preserved for meeting attendees and future reference.  The FDA will issue the 
686  official, finalized minutes to the requester within 30 calendar days after the meeting. 
687   
688  The following are general considerations regarding meeting minutes: 
689   
690    FDA minutes will outline the important agreements, disagreements, issues for further 
691  discussion, and action items from the meeting in bulleted format.  This information does 
692  not need to be in great detail.  The minutes are not intended to represent a transcript of 
693  the meeting. 
694   
695    FDA project managers will use established templates to ensure that all important meeting 
696  information is captured. 
697   
698    The FDA may communicate additional information in the final minutes that was not 
699  explicitly communicated during the meeting (e.g., pediatric requirements, data standards) 
700  or that provides further explanation of discussion topics.  The FDAs final minutes will 
701  distinguish this additional information from the discussion that occurred during the 
702  meeting. 
703   
704    In cases of a WRO, the WRO will serve as the meeting minutes. 
705   
706  The following steps should be taken when a requester disagrees that the minutes are an accurate 
707  account of the meeting: 
708   
709  1.  The requester should contact the FDA project manager and describe the concern.  If, after 
710  contacting the FDA project manager, the requester still disagrees with the content of the 
711  minutes, the requester should submit a description of the specific disagreements to the 
712  application. 
713   
714  2.  The review division and the meeting chair will take the concerns under consideration, and 
715  the FDA will act in one of two ways: 
716   
717    If the minutes are deemed to accurately and sufficiently reflect the meeting 
718  discussion, the FDA project manager will convey this decision to the requester and 
719  the minutes will stand as the official documentation of the meeting. 
720   
721    If the FDA deems it necessary, the FDA will document changes in an addendum to 
722  the official minutes.  The addendum will also document any remaining requester 
723  objections.  
724   
725  For all meeting types, to ensure the sponsors understanding of FDA feedback from meeting 
726  discussions or a WRO, sponsors may submit clarifying questions to the Agency.  Only questions 
727  of a clarifying nature will be permitted (i.e., to confirm something in minutes or a WRO issued 
728  by FDA) rather than raising new issues or new proposals.  The FDA will develop criteria and 
729  parameters for permissible requests, and the FDA may exercise discretion about whether 
730  requests are in scope.  The clarifying questions should be sent in writing as a Request for 
18  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
731  Clarification to the FDA within 20 calendar days following receipt of meeting minutes or a 
732  WRO.  For questions that meet the criteria, the FDA will issue a response in writing within 20 
733  calendar days of receipt of the clarifying questions.  The FDAs response will reference the 
734  original meeting minutes or WRO. 
735   
736  To request information on additional issues that were not addressed at the meeting, the requester 
737  should submit a new meeting request or a submission containing specific questions for FDA 
738  feedback. 
19  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
739  REFERENCES 
740   
741  Related guidances1 
742   
743  Draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of 
744  PDUFA Products (December 2017)2 
745   
746  Draft guidance for review staff and industry Good Review Management Principles and Practices 
747  for New Drug Applications and Biologics License Applications (September 2018)3  
748   
749  Guidance for industry and review staff Best Practices for Communication Between IND 
750  Sponsors and FDA During Drug Development (December 2017) 
751   
752  Guidance for industry and review staff Formal Dispute Resolution:  Sponsor Appeals Above the 
753  Division Level (May 2019) 
754   
755  Guidance for industry Assessing User Fees Under the Biosimilar User Fee Amendments of 2022 
756  (July 2023) 
757   
758  Guidance for industry Providing Regulatory Submissions in Electronic Format  Certain 
759  Human Pharmaceutical Product Applications and Related Submissions Using the eCTD 
760  Specifications (February 2020) 
761   
762  Guidance for industry Providing Regulatory Submissions in Electronic Format  Submissions 
763  Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (December 2014) 
764   
765  Guidance for industry Special Protocol Assessment (April 2018) 
766   
767  Related Center for Biologics Evaluation and Research Standard Operating Policies and 
768  Procedures (SOPPs)4 
769   
770  SOPP 8101.1 Regulatory Meetings With Sponsors and Applicants for Drugs and Biological 
771  Products (March 2023) 
 
1 Guidances are updated periodically.  To make sure you have the most recent version of a guidance, check the 
FDAs guidance web pages at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.   
 
2 When final, this guidance will represent the FDAs current thinking on this topic.  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. 
 
3 When final, this guidance will represent the FDAs current thinking on this topic. 
 
4 SOPPs can be found on the Biologics Procedures (SOPPs) web page at https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-regulatory-information-biologics/biologics-procedures-sopps. 
20