Post-Complete 
Response Letter 
Clarification 
Teleconferences 
Between FDA and 
ANDA Applicants 
Under GDUFA 
Guidance for Industry 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
October 2022 
Generic Drugs 
 
Revision 1 
  Contains Nonbinding Recommendations 
 
Post-Complete 
Response Letter 
Clarification 
Teleconferences 
Between FDA and 
ANDA Applicants 
Under GDUFA 
Guidance for Industry 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
October 2022 
Generic Drugs 
 
Revision 1 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  GDUFA III PERFORMANCE GOALS ......................................................................... 3 
IV.  POST-CRL CLARIFICATION TELECONFERENCE REQUESTS ........................ 4 
V.  ASSESSING POST-CRL CLARIFICATION TELECONFERENCE  
  REQUESTS ....................................................................................................................... 5 
  A.    Teleconference Denied ........................................................................................................... 5 
  B.    Teleconference Granted ......................................................................................................... 6 
  C.    Written Responses Only ........................................................................................................ 7 
VI.   RESCHEDULING AND CANCELLING POST-CRL CLARIFICATION 
TELECONFERENCES .................................................................................................... 8 
VII.  PROCEDURES FOR THE CONDUCT OF POST-CRL CLARIFICATION 
TELECONFERENCES .................................................................................................... 8 
VIII.   DOCUMENTATION AND MEETING MINUTES ...................................................... 8 
IX.   RESOLUTION OF DISPUTES ABOUT MEETING MINUTES ............................... 9 
  Contains Nonbinding Recommendations 
 
Post-Complete Response Letter Clarification Teleconferences 
Between FDA and ANDA Applicants Under GDUFA  
  Guidance for Industry1   
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page.   
 
 
 
 
I.  INTRODUCTION  
 
This guidance provides recommendations to industry on post-complete response letter (CRL) 
teleconferences (post-CRL clarification teleconferences) between FDA and abbreviated new 
drug application (ANDA) applicants for the purpose of clarifying deficiencies identified in a 
CRL to an ANDA2 submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 355(j)).  For purposes of this guidance, a post-CRL clarification 
teleconference is a meeting that is requested in writing by an ANDA applicant pursuant to the 
procedures described in this guidance following receipt of a CRL.3 
 
It is important that there are efficient, consistent procedures for the timely and effective conduct 
of post-CRL clarification teleconferences.  This guidance will assist applicants in generating and 
submitting a request for a post-CRL clarification teleconference and the associated meeting 
package to FDA as contemplated in the Generic Drug User Fee Amendments of 2022, 
reauthorizing the Generic Drug User Fee Amendments (GDUFA III) for Fiscal Years 2023-
2027.  This guidance is intended to provide procedures that will promote well-managed post-
CRL clarification teleconferences and help ensure that such meetings are scheduled and 
conducted in accordance with the time frames set forth in the GDUFA Reauthorization 
 
1 This guidance has been prepared by the Division of Policy Development in the Office of Generic Drug Policy in 
the Center for Drug Evaluation and Research at the Food and Drug Administration. You may submit comments on 
this guidance at any time.  Submit comments to Docket No. FDA-2017-D-5928 (available at 
https://www.regulations.gov/docket/FDA-2017-D-5928).     
2 For purposes of this guidance, ANDA means the original application including all amendments and supplements to 
the application. 
3 Post-CRL clarification teleconferences have a different purpose and different eligibility criteria than post-CRL 
scientific meetings.  For additional information on post-CRL scientific meetings, see the guidance for industry 
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA (October 2022).  For 
the most recent version of a guidance, check the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
  1  Contains Nonbinding Recommendations 
 
Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III 
commitment letter).4  
 
This guidance revises the guidance entitled Post-Complete Response Letter Meetings Between 
FDA and ANDA Applicants Under GDUFA issued in December 2018.  This revision is being 
issued to incorporate the performance goals outlined in the GDUFA III commitment letter that 
FDA has agreed to meet, and clarifies how FDA will conduct post-CRL clarification 
teleconferences subject to the GDUFA performance goals.    
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.   
 
 
II.  BACKGROUND 
 
The Generic Drug User Fee Amendments of 2012 (GDUFA I)5 amended the FD&C Act to 
authorize FDA to assess and collect user fees to provide the Agency with the resources6 to help 
ensure patients have access to quality, affordable, safe, and effective generic drugs.  GDUFA fee 
resources bring greater predictability and timeliness to the review of generic drug applications.  
GDUFA has been reauthorized every 5 years to continue FDAs ability to assess and collect 
GDUFA fees and this user fee program has been reauthorized two times since GDUFA I, most 
recently in the Generic Drug User Fee Amendments of 2022.  As described in the GDUFA III 
commitment letter applicable to this latest reauthorization, FDA has agreed to performance goals 
and program enhancements regarding aspects of the generic drug assessment program that build 
on previous authorizations of GDUFA.  New enhancements to the program are designed to 
maximize the efficiency and utility of each assessment cycle, with the intent of reducing the 
number of assessment cycles for ANDAs and facilitating timely access to generic medicines for 
American patients. 
 
As described in the GDUFA III commitment letter, the purpose of a post-CRL clarification 
teleconference is for applicants to seek clarification concerning deficiencies identified in a CRL.7  
Under the GDUFA III commitment letter, post-CRL clarification teleconferences are available 
for both major and minor CRLs issued in the first cycle or in subsequent assessment cycles.  
FDA will grant any complete post-CRL clarification teleconference request that satisfies the 
criteria outlined in section IV of this guidance.  FDA will only grant post-CRL clarification 
teleconference requests that pose questions to clarify identified deficiencies.  Other issues, 
including questions requiring further Agency review, disputes about classification of complete 
 
4 The GDUFA III commitment letter is available at https://www.fda.gov/media/153631/download.   
5 Title III of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144. 
6 User fees are available for obligation in accordance with appropriations acts.  
7 GDUFA III commitment letter at 16.  
  2  Contains Nonbinding Recommendations 
 
response amendments,8 or new information submitted by the applicant, will not be addressed in a 
post-CRL clarification teleconference.  If applicants have non-clarifying questions in relation to 
a CRL, they can consider requesting a post-CRL scientific meeting9 or submitting a controlled 
correspondence,10 as appropriate.  An applicant may have a post-CRL clarification 
teleconference prior to requesting a post-CRL scientific meeting.11   
 
 
III.  GDUFA III PERFORMANCE GOALS 
 
In accordance with the GDUFA III commitment letter, FDA agreed to certain goals and 
procedures for the scheduling and conduct of post-CRL clarification teleconferences for all 
ANDAs.12   
 
FDA has committed to providing a scheduled date for 90 percent of post-CRL clarification 
teleconferences within 14 calendar days13 of receipt14 of a written request.15  FDA has further 
committed to conducting 90 percent of post-CRL clarification teleconferences, held on an FDA-
proposed date, within 30 days of receipt of a written request.  In the event FDA proposes a post-
CRL clarification teleconference date within 30 days of receipt of a written request, but the 
teleconference is ultimately scheduled outside of the 30-day window at the applicants request, 
 
8 See the draft guidance for industry Requests for Reconsideration at the Division Level Under GDUFA (December 
2017) (when final, this guidance will represent FDAs current thinking on this topic) and the guidance for industry 
ANDA Submissions  Amendments to Abbreviated New Drug Applications Under GDUFA (July 2018) for further 
information on disputing the classification of a complete response amendment.   
9 The purpose of a post-CRL scientific meeting is to provide an applicant scientific advice on possible approaches to 
address deficiencies identified in a CRL related to establishing equivalence.  An applicants post-CRL scientific 
meeting request must discuss one or more of the following: (1) a new equivalence study needed to address the 
deficiencies in the design identified in the CRL; (2) an approach that is different from that submitted in an ANDA 
(e.g., a change in study type from in vivo to in vitro); (3) a new comparative use human factors study; or (4) a new 
approach to demonstrating sameness of a complex active ingredient.  GDUFA III commitment letter at 28-29.  For 
more information on post-CRL scientific meetings, see the guidance for industry Formal Meetings Between FDA 
and ANDA Applicants of Complex Products Under GDUFA (October 2022). 
10 The purpose of the controlled correspondence process is to provide a mechanism for a direct inquiry on FDAs 
position with respect to a particular element of generic drug development or post-approval submission requirements 
and for the Agencys direct, brief, timely response.  For example, an ANDA applicant may submit a controlled 
correspondence to seek regulatory and/or scientific advice after issuance of a CRL or to request evaluations of 
alternative bioequivalence approaches (e.g., pharmacokinetic, in vitro, clinical).  GDUFA III commitment letter at 
11, 46.  For more information on the controlled correspondence process, see the guidance for industry Controlled 
Correspondence Related to Generic Drug Development (December 2020). 
11 GDUFA III commitment letter at 26.  
12 Ibid at 16. 
13 Ibid.  See also the GDUFA III commitment letter at 47, stating that [d]ays  unless otherwise specified, means 
calendar days. 
14 For purposes of meeting the commitments outlined in this guidance, post-CRL clarification teleconference 
requests will be received by the Agency, via the Electronic Submissions Gateway (ESG), Monday through Friday 
from 12:00 a.m. to 11:59 p.m. Eastern Standard Time/Eastern Daylight Time, excluding Federal holidays and days 
when the FDA office that will review the post-CRL clarification teleconference request is closed.   
15 GDUFA III commitment letter at 16.   
  3  Contains Nonbinding Recommendations 
 
FDA will consider its goal of conducting the teleconference within 30 days of receipt of a written 
request met.  
 
 
IV.  POST-CRL CLARIFICATION TELECONFERENCE REQUESTS 
 
To make the most efficient use of FDA and industry resources, any post-CRL clarification 
teleconference request should include the information specified in this section.  If FDA 
determines that the post-CRL clarification teleconference request does not contain the 
information specified in this section, the request is subject to denial (see section V.A). 
 
The written request should be submitted to the ANDA via the Electronic Submissions Gateway 
(ESG) within 10 calendar days of issuance of the CRL to help facilitate planning and 
coordination of a post-CRL clarification teleconference.  The cover page should identify the 
submission as a Post-Complete Response Letter Clarification Teleconference Request.  A 
complete post-CRL clarification teleconference request package should include the following 
information:  
 
  A list of proposed questions seeking clarification of the deficiencies identified in the 
CRL, grouped by assessment discipline and describing the reason why such 
deficiencies are not clear.16  
 
  A list of all individuals, with their titles and affiliations, who will participate in the 
requested teleconference from the applicants organization and consultants.17 
 
  The requested formatteleconference18 or written response only.19  If the requested 
format is a teleconference, the post-CRL clarification teleconference request package 
should also include the following information:  
 
  A proposed agenda outlining how the 30-minute20 time allotted for the post-
o
CRL clarification teleconference should be apportioned to each proposed 
question. 
 
 
16 Ibid.  
17 The applicant should notify their point of contact (POC) immediately if the list of teleconference participants from 
the applicants organization and consultants changes.  In this situation, FDA may reschedule the teleconference if 
the revised list of teleconference participants requires additional FDA personnel.  In the event this teleconference is 
ultimately scheduled outside of the 30-day window, FDA will consider its GDUFA III goal of conducting the 
teleconference within 30 days of receipt of a written request met. 
18 Teleconference means a verbal communication by telephone, and not a written response unless otherwise agreed 
to by the applicant.  GDUFA III commitment letter at 48.  
19 Written response only responses are sent in lieu of a teleconference when requested by or otherwise agreed to by 
the applicant.  If an applicant requests or otherwise agrees to written responses only, the written responses only 
count toward meeting the GDUFA goal.       
20 Consistent with GDUFA I and GDUFA II, post-CRL clarification teleconferences are limited to 30 minutes. This 
30-minute period will not be extended. 
  4  Contains Nonbinding Recommendations 
 
  A list of specific assessment disciplines asked to participate in the requested 
o
teleconference. 
 
 
V.  ASSESSING POST-CRL CLARIFICATION TELECONFERENCE REQUESTS 
 
The applicants point of contact (POC)21 assigned to the ANDA, in collaboration with the 
assessment disciplines, as necessary, will determine whether to grant or deny the post-CRL 
clarification teleconference request and will respond to the applicant as described below. 
 
A.  Teleconference Denied 
 
If a post-CRL clarification teleconference request is missing any of the elements outlined in 
section IV, FDA will deem the request incomplete and subject to denial.   
 
Also, a post-CRL clarification teleconference request may be denied if:   
 
  The proposed questions are not clarifying.   
  The Agency interprets non-clarifying questions to include those that fall under 
o
the following categories:22 
 Facility-related issues, such as plans for the remediation of current 
good manufacturing practice (CGMP) deficiencies or a facilitys 
current CGMP status. 
 Requests for Agency input on study or formulation design. 
 Requests for amendment reclassification (major to minor). 
 Requests for Agency input on a proposed alternative approach to 
address a deficiency.  
 Disputes regarding the relevance of a deficiency. 
 Disputes regarding the determined scale-up and postapproval changes 
(SUPAC) level. 
 Disputes regarding guidance documents. 
 Disputes regarding facility assessment scheduling/timing or tools used. 
  Examples of non-clarifying questions include:   
o
 Does the Agency agree that this alternative statistical method would be 
acceptable?   
 Can the Agency review our proposed protocol for a new study we plan 
to conduct?  
  The proposed questions are outside the scope of the deficiencies identified in the CRL 
(i.e., questions do not reference a specific deficiency from the CRL).  
 
21 For purposes of this guidance, the applicants POC will generally be the regulatory project manager (RPM).  
However, the appropriate discipline project manager will be the applicants POC in lieu of the RPM for post-CRL 
clarification teleconference requests for labeling only supplements or chemistry, manufacturing, and controls (CMC) 
only supplements. 
22 The categories listed here are not intended to be exhaustive. 
  5  Contains Nonbinding Recommendations 
 
  The proposed questions require additional FDA assessment of information (e.g., data) 
to develop a response.  Clarifying questions should not require an expenditure of 
significant FDA resources.  
  The proposed questions are within the scope of questions that are appropriate for a 
post-CRL scientific meeting.23  
  The post-CRL clarification teleconference request is not submitted post-CRL (i.e., it 
is submitted during the assessment cycle, post-Information Request/Discipline 
Review Letter, or after the applicant has already submitted a CRL response).   
  A post-CRL clarification teleconference request was previously granted for the same 
CRL.  
 
If a post-CRL clarification teleconference request is denied, FDA will notify the applicant in 
writing.  To the extent an applicant wishes to resubmit the meeting package and provide any 
missing elements, the applicant may do so.  GDUFA III goal dates, however, are only available 
for original, complete packages submitted within 10 calendar days of issuance of the CRL 
containing proposed questions that are within the scope of the CRL and otherwise meet the 
criteria set forth in section IV.  Thus, if a resubmitted post-CRL clarification teleconference 
request is granted, there will be no GDUFA III goal dates associated with scheduling and 
conducting the post-CRL clarification teleconference.     
  
B.  Teleconference Granted  
 
A post-CRL clarification teleconference request may be granted if the following criteria are 
satisfied: 
 
  A post-CRL clarification teleconference request has not already been granted for the 
same CRL. 
  FDA will generally grant only one post-CRL clarification teleconference 
o
request (either teleconference or written response only as requested by the 
applicant) per CRL, covering only those clarifying questions submitted in a 
single complete post-CRL clarification teleconference request package.   
 
  The proposed questions seek clarification concerning deficiencies identified in the 
CRL. 
  The GDUFA III commitment letter defines appropriate requests as ones that 
o
clearly identify the specific deficiencies to be discussed and the reason why 
such deficiencies are not clear, considered clarifying questions for purposes of 
this guidance.24  Clarifying questions should not require additional FDA 
assessment of information (e.g., data) to develop a response or require an 
expenditure of significant Agency resources.  
  The Agency interprets clarifying questions to include, for example, requests 
o
for clarification on requirements to address a deficiency.   
 
23 See footnote 9.   
24 GDUFA III commitment letter at 16. 
  6  Contains Nonbinding Recommendations 
 
 
  A complete meeting package is submitted, as outlined in section IV. 
   
Applicants should include all questions in their complete post-CRL clarification teleconference 
request packages, rather than submitting questions on a rolling basis, as the Agency will not 
consider subsequently submitted questions. 
 
Goal dates are only available for original, complete packages submitted within 10 calendar days 
of issuance of the CRL containing proposed questions that are within the scope of the CRL and 
otherwise meet the criteria set forth in section IV.  If an original, complete post-CRL 
clarification teleconference package is submitted outside the 10-calendar-day window, the 
teleconference request may be granted but will be ineligible for a goal date assignment. 
   
If a post-CRL clarification teleconference request is granted, the applicant will be notified in 
writing.   
 
Post-CRL clarification teleconference requests that contain clarifying questions and non-
clarifying questions may be granted in part for the clarifying questions and denied in part for the 
non-clarifying questions.   
 
If applicants have non-clarifying questions, they can consider requesting a post-CRL scientific 
meeting25 or submitting a controlled correspondence,26 as appropriate, to obtain the Agencys 
feedback on those non-clarifying questions.     
 
C.  Written Responses Only 
 
FDA has agreed to grant or deny an applicants post-CRL clarification teleconference request for 
written responses only within 14 calendar days of receipt of a written request, and the applicant 
will be notified in writing.  If the applicants request is granted, FDA has agreed to provide 
written responses only in lieu of a teleconference within 30 days of receipt of a post-CRL 
clarification teleconference request requesting written responses only.27  FDA will generally 
grant only one post-CRL clarification teleconference request (either teleconference or written 
response only as requested by the applicant) per CRL, covering only clarifying questions 
submitted in a single complete post-CRL clarification teleconference request package.  
 
 
 
 
 
 
 
 
25 See footnote 9.   
26 See footnote 10.   
27 GDUFA III commitment letter at 16. 
  7  Contains Nonbinding Recommendations 
 
 
VI.   RESCHEDULING AND CANCELLING POST-CRL CLARIFICATION 
TELECONFERENCES 
 
Occasionally, circumstances arise that necessitate the rescheduling or cancellation of a post-CRL 
clarification teleconference.  If a post-CRL clarification teleconference must be rescheduled, it 
should be rescheduled as soon as possible after the original date.  A new post-CRL clarification 
teleconference request should not be submitted.  The applicant and FDA should take reasonable 
steps to avoid rescheduling teleconferences.  It will be at the discretion of the applicable 
assessment discipline(s) whether the teleconference should be rescheduled depending on the 
specific circumstances.  A teleconference may be rescheduled if, for example: 
 
  It is determined that attendance by additional FDA personnel not originally anticipated 
or requested is critical and their availability precludes holding the teleconference on 
the original date. 
  Essential attendees are no longer available for the scheduled date and time because of 
an unexpected or unavoidable conflict or an emergency situation.  
 
A post-CRL clarification teleconference may be cancelled if, for example, the ANDA applicant 
withdraws the post-CRL clarification teleconference request or if the applicant submits a 
response to the CRL. 
 
 
VII.  PROCEDURES FOR THE CONDUCT OF POST-CRL CLARIFICATION 
TELECONFERENCES 
 
Post-CRL clarification teleconferences will be facilitated by the applicants POC assigned to the 
ANDA and will begin with introductions and a statement of the agenda.  FDA will strictly follow 
the agenda and will not entertain questions outside the clarifying questions submitted in the post-
CRL clarification teleconference request package.  Consistent with GDUFA I and GDUFA II, 
post-CRL clarification teleconferences are limited to 30 minutes.  This 30-minute teleconference 
period cannot be extended.28  To the extent questions on the agenda are addressed ahead of the 
expiration of this 30-minute period, the teleconference will end upon the conclusion of 
discussions related to these questions. 
 
Before the end of the teleconference, FDA recommends that all attendees summarize discussion 
points, agreements, and clarifications to ensure that there is a mutual understanding of the 
teleconference outcomes. 
 
 
VIII.   DOCUMENTATION AND MEETING MINUTES 
 
Documentation of teleconference outcomes (responses to the questions and outcomes of any 
discussions regarding the responses), agreements, and disagreements is critical to ensuring that 
 
28 In consideration of the time constraints of post-CRL clarification teleconference, FDA encourages applicants to 
carefully consider the order in which they would like FDA to address their questions. 
  8  Contains Nonbinding Recommendations 
 
this information is preserved for teleconference participants and for future reference.  FDA 
meeting minutes are the official record of the teleconference.  FDA intends to issue the official, 
finalized minutes to the ANDA applicant within 30 days of the post-CRL clarification 
teleconference. 
 
 
IX.   RESOLUTION OF DISPUTES ABOUT MEETING MINUTES 
 
On occasion, there may be disputes regarding the accuracy and sufficiency of the minutes of a 
post-CRL clarification teleconference.  An ANDA applicant requesting additional clarification of 
the meeting minutes issued by FDA should contact the applicants POC in writing within 10 
calendar days of receipt of the meeting minutes.  This process addresses issues with the meeting 
minutes only and not additional issues that were not addressed at the post-CRL clarification 
teleconference.    
 
The ANDA applicants concerns will be taken under consideration by the assessment discipline 
and senior management if senior management were present at the teleconference.  If the minutes 
are deemed to accurately and sufficiently reflect the teleconference discussion, the applicants 
POC will convey this decision to the ANDA applicant and the minutes will stand as the official 
documentation of the teleconference.  If, after discussions with the ANDA applicant, FDA deems 
it necessary to effect a change to the official minutes, the changes will be documented in an 
addendum to the official minutes.  The addendum will also document any continued objections 
from the ANDA applicant.29  
 
29 Any addendum will be shared with the ANDA applicant by FDA.   
  9