Formal Dispute Resolution:  
Sponsor Appeals Above the 
Division Level 
Guidance for Industry and Review 
Staff 
 
Good Review Practice 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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) 
 
November 2017 
Procedural 
 
Revision 1 
 
OMB Control Number 0910-0001 
Current expiration date available at https://www.reginfo.gov 
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See additional PRA statement in section VII of this guidance. 
 
   
Formal Dispute Resolution:  
Sponsor Appeals Above the 
Division Level 
Guidance for Industry and Review 
Staff 
 
Good Review Practice 
 
Additional copies are available from: 
 
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Center for Drug Evaluation and Research 
Food and Drug Administration 
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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) 
 
November 2017 
Procedural 
 
Revision 1 
   
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
A.  Regulatory Framework ................................................................................................................. 2 
B.  Formal Dispute Resolution User Fee Performance Goals .......................................................... 3 
III.  CONSIDERATIONS FOR SPONSORS:  BEFORE SUBMITTING A REQUEST 
FOR FORMAL DISPUTE RESOLUTION ................................................................... 4 
A.  What Is an Appropriate Matter for a Formal Dispute Resolution Request? ........................... 4 
B.  When Is a Matter Not Appropriate for a Formal Dispute Resolution Request? ..................... 5 
C.  Is There New Information and/or Are There New Analyses of Previously Reviewed Data 
That the Sponsor Believes Is/Are Relevant? ................................................................................ 6 
D.  Can a Sponsor Request a Meeting as Part of an FDRR? ........................................................... 6 
E.  Can a Sponsor Request an Advisory Committee Meeting as Part of FDR? ............................. 7 
IV.  PROCEDURES FOR SUBMITTING A REQUEST FOR FORMAL DISPUTE 
RESOLUTION .................................................................................................................. 7 
A.  How to Request Formal Dispute Resolution ................................................................................ 7 
1. Requests for CDER .......................................................................................................................... 7 
2. Requests for CBER ........................................................................................................................... 7 
B.  Content and Format of an FDRR ................................................................................................. 8 
V.  FDA ACTION ................................................................................................................... 9 
A.  Responses to an Appeal ................................................................................................................. 9 
1. Timelines for Reviewing Formal Dispute Resolution Requests for Human Drug Applications 
Covered by PDUFA, BsUFA, or GDUFA ..................................................................................... 10 
2. Timelines for Reviewing Formal Dispute Resolution Requests for Applications and Submissions 
Not Covered by PDUFA, BsUFA, or GDUFA ............................................................................... 11 
B.  Additional Considerations Regarding Responses to Appeals That Request Advisory 
Committee Review ....................................................................................................................... 11 
1. Granting a Request for Advisory Committee Review ..................................................................... 11 
2. Denial of a Request for Advisory Committee Review .................................................................... 12 
VI.  REPEAT APPEALS ....................................................................................................... 12 
VII.  PAPERWORK REDUCTION ACT OF 1995 .............................................................. 12 
  Contains Nonbinding Recommendations 
Formal Dispute Resolution: 
Sponsor Appeals Above the Division Level 
Guidance for Industry and Review Staff1 
 
Good Review Practice 
 
 
 
 
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 for industry and review staff on the procedures in the 
Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and 
Research (CBER) for resolving scientific and/or medical disputes2 between CDER or CBER and 
sponsors3 that cannot be resolved at the division level.  This guidance describes the formal 
dispute resolution (FDR) procedures for sponsors that wish to appeal4 a scientific and/or medical 
issue to the office or center level and provides a structured process for resolving disputes.  
 
During the course of review of an investigational new drug application (IND), new drug 
application (NDA), biologics license application (BLA), or abbreviated new drug application 
(ANDA), a wide variety of important scientific and/or medical issues are considered that are 
central to product development.  Sometimes, a sponsor may disagree with the Agency on a 
matter, and a dispute arises.  Because these disputes often involve complex scientific and/or 
 
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 The FDA considers scientific and/or medical disputes to encompass procedural matters that may arise in the 
context of a larger scientific and/or medical dispute.  For example, if a sponsor is disputing a clinical hold action for 
an investigational new drug application (IND), the formal dispute resolution request could include consideration of 
related procedural matters, such as inadequate communication between the sponsor and the review division at the 
time of the clinical hold decision.  
 
3 For purposes of this guidance, the term sponsor includes any sponsor of an IND or applicant for a new drug 
application, abbreviated new drug application, or biologics license application under section 505 of the Federal 
Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.     
 
4 For purposes of this guidance, an appeal is a sponsor request for FDR.   
  1  Contains Nonbinding Recommendations 
medical matters, it is critical to have procedures in place to help ensure open and prompt 
discussion.  The procedures and policies described in this guidance are intended to promote rapid 
and fair resolution of scientific and/or medical disputes between a sponsor and CDER or CBER.5   
 
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.  Although guidance documents do not legally bind the FDA, review staff may 
depart from guidance documents only with appropriate justification and supervisory 
concurrence. 
 
 
II.  BACKGROUND 
 
A.  Regulatory Framework 
 
In 1997, Congress enacted section 562 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-1), which directed the FDA to ensure that it had adequate dispute resolution procedures 
to provide for appropriate review of scientific controversies between the FDA and members of 
regulated industry, including possible review by a scientific advisory committee.6  The Agencys 
implementation of section 562 was two-fold.  First, the FDA amended 21 CFR 10.75, the general 
appeal regulation applicable across all FDA components, to provide for advisory committee 
review (21 CFR 10.75(b)(2); 63 FR 63978, November 18, 1998).  Second, the Agency adopted 
an individual, center-based approach to the specific implementation of section 562s mandates, 
which would be detailed in center-issued guidances (63 FR at 63979).  
 
At the time of section 562s enactment, in addition to the general, Agency-wide regulation set 
forth at 21 CFR 10.75, CDER and CBER had dispute resolution regulations that pertained to the 
IND and NDA processes (21 CFR 312.48, 314.103).  Nonetheless, in response to the enactment 
of section 562, CDER and CBER created FDR.  The guidance for industry Formal Dispute 
Resolution:  Appeals Above the Division Level issued in February 2000 (2000 guidance) outlined 
the basic elements of FDR.  The 2000 guidance brought together under the FDR umbrella 
 
5 This guidance does not apply to purely internal disputes involving FDA staff.  Additionally, this guidance is not 
intended to address the alternate dispute resolution pathway of appealing a dispute to the Drug Safety Oversight 
Board that exists for risk evaluation and mitigation strategies modified or required after initial drug approval 
(21 U.S.C. 355-1(h)(5)).  For guidance on how to resolve disputes of scientific and technical issues relating to 
current good manufacturing practice requirements, see the guidance for industry Formal Dispute Resolution:  
Scientific and Technical Issues Related to Pharmaceutical CGMP.  We update guidances periodically.  To make 
sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
 
6 Although section 562 refers to obligations concerning both drugs and devices, this guidance addresses FDR only as 
it pertains to CDER- and CBER-regulated products.  Medical devices regulated by CBER are addressed in section 
II.B., Formal Dispute Resolution User Fee Performance Goals, and section V.A.2., Timelines for Reviewing Formal 
Dispute Resolution Requests for Applications and Submissions Not Covered by PDUFA, BsUFA, or GDUFA.  This 
guidance does not address FDR for medical devices regulated by the Center for Devices and Radiological Health.    
  2  Contains Nonbinding Recommendations 
various regulatory appeal mechanisms as they relate to CDER- and CBER-regulated user fee 
products.   
 
As set forth in more detail below, FDR is intended to address scientific and/or medical disputes 
between a sponsor and CDER or CBER as such disputes relate to the sponsors application for a 
product covered by user fee goals (user fee products).  As such, CDER and CBER intend to 
manage any formal sponsor request7 for appeal of a scientific and/or medical matter related to an 
application for a user fee product under any of the available regulatory mechanisms (21 CFR 
10.75, 312.48(c), 314.103(c)), through the FDR process.8  Any sponsor appeal of a scientific 
and/or medical matter proceeds to the next management level in the center chain of command 
above the level at which the decision being appealed was made.  However, regardless of the 
regulatory mechanism cited by a sponsor, if a sponsor challenges specific administrative and/or 
procedural decisions that arise during the course of an FDR, CDER and CBER intend to review 
these interim decisions as part of the review of the pending substantive scientific and/or medical 
dispute, and not as a separate review.  
 
B.  Formal Dispute Resolution User Fee Performance Goals 
 
In the Prescription Drug User Fee Act of 1992 (PDUFA) and subsequent reauthorizations,9 
CDER and CBER agreed to specific performance goals for activities associated with the 
development and review of human drug applications, as defined in 21 U.S.C. 379g.  These 
performance goals contain specific time frames for resolving disputes affecting an IND, NDA, or 
BLA.  For disputes involving human drug applications covered by PDUFA, the PDUFA goal is 
to respond to an appeal of a dispute above the original signatory authority within 30 calendar 
 
7 As stated earlier, this guidance describes the FDR procedures for sponsors that wish to appeal a scientific and/or 
medical issue regarding their application regulated by CDER or CBER.  The guidance and procedures do not apply 
to other individuals or entities that wish to appeal a scientific and/or medical issue regarding an application regulated 
by CDER or CBER.  To the extent that 21 CFR 10.75(c) may provide a separate mechanism for nonsponsors to 
request internal Agency review of a CDER or CBER decision on a scientific and/or medical issue regarding an 
application or submission, any such review is discretionary.  Except in unusual circumstances, CDER and CBER 
generally do not intend to accept requests by nonsponsors for internal Agency review of a scientific and/or medical 
issue regarding an application or submission.  The Agency believes that it is highly unlikely that an individual or 
entity other than the sponsor would have access to the information necessary to support a request for internal 
Agency review of these types of decisions.  The Agency also believes that it is highly unlikely that a nonsponsor 
would be in a position to evaluate any product development considerations that may be affected by an Agency 
decision for which a nonsponsor might wish to request internal Agency review.   
 
8 A sponsor seeking informal resolution of a specific issue, including, but not limited to, a procedural or 
administrative matter regarding a product, may raise the issue with the appropriate center ombudsman (21 CFR 
312.48(b), 314.103(b)).  CDER and CBER ombudsmen informally investigate and facilitate resolution of such 
issues.  Such informal contacts with the ombudsman concerning human drug applications are not subject to user fee 
goals.  It is important to note that although sponsors may seek informal advice from the ombudsman at any time, 
they should not engage the ombudsman in this manner and, at the same time, pursue FDR.  Moreover, such requests 
for ombudsman assistance are outside the scope of FDR and this guidance.  
 
9 In the PDUFA performance goals and procedures letter (available at 
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm), PDUFA performance goals for 
FDR are listed under Major Dispute Resolution.  CDER and CBER consider FDR and major dispute resolution to be 
synonymous.  Although CBER employs the FDR process for all of its products, outcome reporting under PDUFA 
performance goals includes only those issues that involve PDUFA products.   
  3  Contains Nonbinding Recommendations 
days of the centers receipt of the written appeal (see section V.A.1., Timelines for Reviewing 
Formal Dispute Resolution Requests for Human Drug Applications Covered by PDUFA, 
BsUFA, or GDUFA).   
 
In the Biosimilar User Fee Act of 2012 (BsUFA), CDER and CBER agreed to specific 
performance goals for the review of biosimilar biological applications.10  For disputes involving 
human drug applications covered by BsUFA, the BsUFA goal is to respond to an appeal of a 
dispute above the original signatory authority within 30 calendar days of the centers receipt of 
the written appeal (see section V.A.1., Timelines for Reviewing Formal Dispute Resolution 
Requests for Human Drug Applications Covered by PDUFA, BsUFA, or GDUFA). 
 
In the 2017 reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA), 
CDER agreed to specific performance goals for the review of generic drug applications.11  For 
disputes involving human drug applications covered by GDUFA, the GDUFA goal is to respond 
to an appeal of a dispute above the original signatory authority within 30 calendar days of the 
centers receipt of the written appeal (see section V.A.1., Timelines for Reviewing Formal 
Dispute Resolution Requests for Human Drug Applications Covered by PDUFA, BsUFA, or 
GDUFA). 
 
For those applications not covered by PDUFA, BsUFA, or GDUFA, and for applications or 
submissions for CBER-regulated medical devices (covered by the Medical Device User Fee 
Act), the procedures described in this guidance generally will be applied and the time frames will 
be met as resources permit (see section V.A.2., Timelines for Reviewing Formal Dispute 
Resolution Requests for Applications and Submissions Not Covered by PDUFA, BsUFA, or 
GDUFA).   
 
 
III.  CONSIDERATIONS FOR SPONSORS:  BEFORE SUBMITTING A REQUEST 
FOR FORMAL DISPUTE RESOLUTION  
 
A.  What Is an Appropriate Matter for a Formal Dispute Resolution Request? 
 
CDER and CBER consider a regulatory action taken by the FDA that relates to a sponsors 
application for a user fee product and has scientific and/or medical significance to be a matter 
that could be appropriately handled through FDR.  The following are a few examples of 
regulatory actions that would be appropriate for a request for FDR:  
 
 
10 In the BsUFA performance goals and procedures letter (available at 
https://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/default.htm), BsUFA performance goals 
for FDR are listed under Major Dispute Resolution.  CDER and CBER consider FDR and major dispute resolution 
to be synonymous.   
 
11 In the GDUFA performance goals and procedures letter (available at 
https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm), GDUFA performance goals for 
FDR are listed under Dispute Resolution. 
  4  Contains Nonbinding Recommendations 
  Complete response (CR)  
  IND clinical hold (partial or full)  
  Request for breakthrough therapy designation denied  
  Request for proprietary name review denied  
  Refuse to receive for an ANDA 
 
B.  When Is a Matter Not Appropriate for a Formal Dispute Resolution 
Request? 
 
Advice communicated in meeting minutes and other correspondences is not a regulatory action 
taken by CDER or CBER; therefore, it would not be an appropriate subject for a formal dispute 
resolution request (FDRR) by a sponsor.  Agency communications such as meeting minutes or 
other correspondences (e.g., general advice letters) typically include recommendations and/or 
advice made to a sponsor that generally conveys CDERs or CBERs current thinking on a 
particular topic raised by the sponsor.  Sponsors are not bound by such recommendations and/or 
advice.12  Sponsors can follow the advice in meeting minutes or other correspondences, or they 
can use an alternative approach, if the approach satisfies the requirements of the applicable 
statutes and regulations.  Also, sponsors may approach the review division and/or the next 
highest management level to further discuss advice provided in meeting minutes or other 
correspondences related to their clinical development program outside of an FDRR.  For 
example, sponsors may request a Type C guidance meeting under PDUFA, a biosimilar 
biological product development (BPD) Type 2 meeting under BsUFA, or a meeting under 
GDUFA with the review division, and request the next highest management level be present at 
the meeting (typically in a nondecisional capacity).  
 
CDER and CBER recommend that before submitting an FDRR, the sponsor should ask the 
review division or the office that made the decision to reconsider the FDR-related issue(s).  
Moreover, to further ensure efficient use of Agency resources, the sponsor submitting an FDRR 
should not actively engage with other entities within the FDA or pursue other regulatory or legal 
pathways on the same matter at the same time.  The following are examples of such 
circumstances.  
 
  A sponsors IND is placed on clinical hold, but the sponsor has not asked the review 
division to reconsider the clinical hold action, or a sponsor received a CR letter and has 
requested and been granted a post-action meeting with the division but has not yet 
participated in that post-action meeting.  CDER and CBER do not intend to accept an 
FDRR until the sponsor has taken these steps.  Under FDR, consistent with 21 CFR 
10.75, 312.48, and 314.103, when a scientific and/or medical dispute arises, the sponsor 
should initially seek reconsideration of the matter with the original deciding official 
before making an appeal to the next higher management level.  The FDA notes that no 
new information and/or new analysis of previously reviewed data should be submitted as 
part of a request for reconsideration.  
 
 
12 For example, 21 CFR 312.41, relating to Agency comment and advice on an IND, expressly states that FDA 
communications with a sponsor under this section are solely advisory and do not require any modification in the 
planned or ongoing clinical investigations or response to the Agency.   
  5  Contains Nonbinding Recommendations 
  A sponsor anticipates receiving a CR action and submits an FDRR before receiving the 
CR letter.  CDER and CBER do not intend to accept the FDRR until the sponsor has 
received the CR letter and unsuccessfully attempted to resolve the concern(s) with the 
review division (e.g., has submitted a request for an end-of-review meeting to discuss the 
matter with the review division, participated in such a meeting, and received a response 
from the review division indicating that its decision remains the same).  
 
  A sponsor receives a CR action and has submitted a request for an end-of-review meeting 
to discuss the matter with the review division.  At the same time, the sponsor submits an 
FDRR to the next management level.  CDER and CBER do not intend to accept the 
appeal at that time because the sponsor has not yet attempted to resolve the concern(s) 
with the review division, nor received a response from the review division indicating that 
its decision remains the same.  
 
  A sponsor submits an FDRR that is accepted and the deciding official13 on the appeal 
issues an interim response to the sponsor (see section V., FDA Action).  The sponsor then 
submits an FDRR to appeal the interim response to the next management level.  CDER 
and CBER do not intend to accept the appeal to the next management level until a final 
decision on the appeal has been made at the lower management level. 
 
  A sponsor submits a Petition for Stay of Action under 21 CFR 10.35(b) and, for the same 
matter, several days later submits an FDRR.  CDER and CBER do not intend to accept 
the FDRR because the sponsor is already engaged in another regulatory/legal proceeding 
within the Agency regarding the scientific and/or medical matter in dispute.  
 
C.  Is There New Information and/or Are There New Analyses of Previously 
Reviewed Data That the Sponsor Believes Is/Are Relevant? 
 
Because internal Agency review of a decision that has been appealed by a sponsor must be based 
on the same information as was relied on to make the original decision (i.e., information already 
in the relevant administrative file; 21 CFR 10.75(d)), no new information should be submitted as 
part of an FDRR.  If the sponsor wants to have CDER or CBER consider new information that 
may affect the original decision on a matter, it should submit the new information to the 
sponsors application (i.e., IND, NDA, BLA, or ANDA) for review by the division and the 
original deciding official.  CDER and CBER consider new analyses of previously reviewed data 
to be new information because the original deciding official might have made a different 
decision had he or she had the opportunity to review the new analyses.   
 
D.  Can a Sponsor Request a Meeting as Part of an FDRR? 
 
After a sponsor has decided to submit an FDRR, as part of the appeal, it can request a meeting 
with the deciding official for the appeal (e.g., a Type A meeting for human drug applications 
covered by PDUFA, a BPD Type 1 meeting for human drug applications covered by BsUFA, or 
 
13 For purposes of this guidance, the term deciding official refers to the person assigned to make the decision on the 
appeal. 
  6  Contains Nonbinding Recommendations 
a meeting for a human drug application covered by GDUFA).14  This meeting is an opportunity 
for the sponsor to discuss the appeal issue(s) with the deciding official for the appeal.  
 
E.  Can a Sponsor Request an Advisory Committee Meeting as Part of FDR? 
 
As part of an original appeal or at any point in the FDR process, a sponsor can request that a 
scientific dispute be reviewed by an appropriate advisory committee.  Because it can take a 
significant amount of time to schedule an advisory committee meeting, if a sponsor believes that 
review by an advisory committee is the most appropriate venue for resolution of a scientific 
controversy, such a sponsor request should be made as early in the dispute resolution process as 
feasible.   
 
 
IV.  PROCEDURES FOR SUBMITTING A REQUEST FOR FORMAL DISPUTE 
RESOLUTION  
 
A.  How to Request Formal Dispute Resolution 
 
The sponsor should submit an FDRR to the sponsors application as described below.  Before 
submitting a request, it is strongly encouraged that the sponsor contacts CDER or CBER and 
provides advance notice of the sponsors intent to submit an FDRR to ensure prompt handling of 
the appeal.  Contact information for each Center is provided below.   
 
1.  Requests for CDER 
 
Requests for FDR with CDER should be submitted to the sponsors application.  The request 
should be submitted as an amendment to the appropriate application file (IND, NDA, BLA, or 
ANDA) and a copy should be submitted to the CDER Formal Dispute Resolution Project 
Manager (FDRPM).  The contact information can be found on the CDER Formal Dispute 
Resolution web page.15  CDER encourages sponsors to contact the FDRPM before submitting a 
request for FDR. 
 
2.  Requests for CBER 
 
Requests for FDR with CBER should be submitted to the sponsors application when the request 
relates to an active submission.  The request should be submitted as an amendment to the 
application to the appropriate review division, and a copy sent to the CBER Ombudsman.  The 
 
14 See the guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants for human drug 
applications covered by PDUFA.  (In March 2015, the FDA issued the revised draft guidance Formal Meetings 
Between the FDA and Sponsors or Applicants of PDUFA Products.  When final, this guidance will represent the 
FDAs current thinking on this topic.)  See the guidance for industry Formal Meetings Between the FDA and 
Biosimilar Biological Product Sponsors or Applicants for biosimilar biological product applications covered by 
BsUFA.  
 
15 See 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/ucm44
4092.htm. 
  7  Contains Nonbinding Recommendations 
contact information can be found on the CBER Ombudsman web page.16  CBER encourages 
sponsors to contact the CBER Ombudsman before submitting a request for FDR.  Note that the 
CBER Ombudsman handles both informal requests and FDRRs, so if the sponsor intends to 
submit an FDRR, it should be clear in its submission that the request is an FDRR.   
 
B.  Content and Format of an FDRR 
 
To make the most efficient use of CDER or CBER and industry resources, any FDRR to either 
CDER or CBER should include information adequate to explain the nature of the scientific 
and/or medical dispute, and to allow the deciding official to determine the necessary steps 
needed to resolve the matter quickly and efficiently.  Each request should include the following: 
 
  Identification of the sponsors submission as FORMAL DISPUTE RESOLUTION 
REQUEST in bold, uppercase letters 
 
  The application number for the IND, NDA, BLA, or ANDA, if applicable 
 
  The proprietary and/or generic name and established name for drug products; the 
proprietary and/or proper name for biological products 
 
  The division or office where the application is filed 
 
  The proposed indication(s), if applicable 
 
  A brief, but comprehensive statement of each issue to be resolved, including: 
 
  A description of the scientific and/or medical matter to be resolved 
 
  A statement of the steps that have been taken to resolve the dispute, including a 
summary of relevant regulatory history, and any previous FDRRs 
 
  A statement of the sponsors proposed possible solutions and/or outcomes 
 
  A statement identifying the division and/or office that issued the decision on the matter 
being disputed and, if applicable, the deciding official on any prior FDRRs related to the 
same scientific and/or medical dispute 
 
  A statement of whether the sponsor is requesting a meeting with the deciding official and 
what type of meeting is requested 
 
  A statement of whether the sponsor is requesting advisory committee review 
 
 
16 See 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122881.htm. 
  8  Contains Nonbinding Recommendations 
  A list of documents previously submitted to the sponsors application that are deemed 
necessary for resolution of the matter, with reference to submission dates so the 
documents can be readily located  
 
  A statement that no new information has been submitted in support of the FDRR and, if 
applicable, that the last deciding official received and had the opportunity to review all of 
the material now being relied upon for the sponsors FDRR  
 
  The name, title, and contact information (i.e., mailing address, email address, telephone 
number, fax number) for the sponsors contact for the appeal   
 
 
V.  FDA ACTION 
 
The FDRPM or CBER Ombudsman functions as the administrative contact for all issues related 
to FDRRs.  The FDRPM or CBER Ombudsman is responsible for communicating and 
explaining all regulatory processes related to FDR to the sponsor.  The FDRPM or CBER 
Ombudsman will conduct a preliminary review of the sponsors FDRR to evaluate whether the 
appeal satisfies the procedural criteria (as described in section IV., Procedures for Submitting a 
Request for Formal Dispute Resolution) so that the FDRR can be accepted.  If the sponsors 
FDRR is accepted, the FDRPM or CBER Ombudsman will forward the appeal to the appropriate 
CDER or CBER management level, as established under the center chain of command.  The 
FDRPM or CBER Ombudsman will also send an acknowledgment letter to the sponsor 
identifying the deciding official, the due date for response to the FDRR, and the date of any 
meeting (if applicable).  If an FDRR is not accepted, the FDRPM or CBER Ombudsman will 
send a letter to the sponsor on behalf of the deciding official identifying the reasons why the 
request was not accepted and outlining a possible path forward for acceptance of the sponsors 
FDRR.  Additionally, if a request for FDR is inappropriately submitted to CDER or CBER, then 
the FDRPM or CBER Ombudsman will re-direct the request to the appropriate entity within the 
FDA.  
 
A.  Responses to an Appeal  
 
In general, the deciding official will send a written decision to a sponsor who submits an FDRR 
that is accepted for review.  The written decision will grant or deny the appeal.  If the deciding 
official does not agree with the sponsors proposed outcome, he or she should provide the 
reasons for not agreeing with the sponsors proposal and possibly suggest other options to 
achieve resolution and identify any actions that the sponsor can take to address the concerns 
articulated by the deciding official.  Before issuing a final decision on the FDRR to the sponsor, 
the deciding official may also provide an interim response, such as a request for additional 
clarifying information or a request for a meeting with the sponsor, before making a decision on 
the appeal.  An interim response should provide an explanation as to why an interim response is 
being issued instead of a final decision on the appeal.  
 
  9  Contains Nonbinding Recommendations 
1.  Timelines for Reviewing Formal Dispute Resolution Requests for Human Drug 
Applications Covered by PDUFA, BsUFA, or GDUFA  
 
As noted earlier, if a scientific and/or medical dispute concerns a human drug application 
covered by PDUFA, BsUFA, or GDUFA, the deciding official should complete his or her review 
and provide an interim response or a decision on the appeal to the sponsor within 30 calendar 
days from receipt of an FDRR that has been accepted.  The deciding official should respond to 
the sponsor within the 30-day window in writing or by telephone (i.e., 30-day response).  If the 
response is by telephone, the deciding official should follow up with a written confirmation 
within 14 calendar days of the verbal response.   
 
If the sponsor requests a meeting as part of its appeal, CDER or CBER should treat the meeting 
request as a Type A meeting under PDUFA, a BPD Type 1 meeting under BsUFA, or a meeting 
under GDUFA.  If the meeting is granted, the deciding official should provide an interim 
response or a decision on the FDRR to the sponsor within 30 calendar days of the meeting date.  
This time period allows the deciding official to consider the discussion at the meeting in his or 
her decision making process. 
 
There may be instances when, to reach a decision, the deciding official needs additional 
clarifying information or input from other persons knowledgeable about the specific matter in 
dispute, or about the issue or area more generally.  In such situations, the deciding official should 
issue an interim response to the sponsor identifying the additional information or input needed.  
If the product is a human drug application covered by PDUFA, BsUFA, or GDUFA, such 
interim responses should be made within 30 calendar days of receipt of the appeal.  
 
  In instances when the deciding official needs clarifying information from the sponsor,17 
a request for this information should be sent within 30 calendar days from receipt of the 
appeal.  The deciding official should provide an interim response or a decision on the 
appeal within 30 calendar days from receipt of the clarifying information submitted to the 
sponsors application.   
 
  In instances when the deciding official decides a meeting with the sponsor is needed 
before a response can be issued, a meeting request should be sent within 30 calendar days 
from receipt of the sponsors FDRR.  CDER or CBER should schedule any meetings as 
quickly as the sponsor and the FDA are able to agree on a mutually acceptable date and 
time.  After the meeting is held, the deciding official should provide an interim response 
or a decision on the appeal to the sponsor within 30 calendar days from the meeting date.   
 
  In instances when the deciding official needs to discuss an FDRR with one or more 
members of an advisory committee or internal or external experts, CDER or CBER 
should inform the sponsor that the deciding official is seeking this additional input within 
30 calendar days from receipt of the sponsors FDRR.  CDER or CBER should schedule 
 
17 Clarifying information does not include new information or reanalysis of data that has not been reviewed by the 
division.  As stated previously, the FDA considers new analyses of previously reviewed data to be new information 
because the original deciding official might have made a different decision had he or she had the opportunity to 
review the new analysis. 
  10  Contains Nonbinding Recommendations 
such discussions with the members of an advisory committee or internal or external 
experts as quickly as possible.  After this discussion takes place, the deciding official 
should provide an interim response or a decision on the appeal to the sponsor within 30 
calendar days from the date of the discussion.   
 
  In instances when the deciding official decides to seek input from an advisory committee, 
CDER or CBER should inform the sponsor of this request within 30 calendar days from 
receipt of the sponsors FDRR.  The deciding official should provide an interim response 
or a decision on the appeal to the sponsor within 30 calendar days after the date of the 
advisory committee meeting. 
 
If the deciding official is unable to complete the review and provide either an interim response or 
a decision on the FDRR to the sponsor within 30 calendar days, CDER or CBER should notify 
the sponsor, explain the reasons for the delay, and provide the anticipated time frame for 
completing the review.  In these cases, the PDUFA, BsUFA, or GDUFA goal for the appeal 
response would not be met. 
 
2.  Timelines for Reviewing Formal Dispute Resolution Requests for Applications 
and Submissions Not Covered by PDUFA, BsUFA, or GDUFA  
 
For FDRRs related to applications not covered by PDUFA, BsUFA, or GDUFA, or related to 
applications or submissions for CBER-regulated medical devices (covered by the Medical 
Device User Fee Act), the timelines described in this guidance will be met as resources permit.  
 
The FDA should provide a written or telephone response to the sponsor in a timely manner.  If 
the response is by telephone, CDER or CBER should follow up with a written confirmation to 
the sponsor within 14 calendar days of the verbal notification.  
 
B.  Additional Considerations Regarding Responses to Appeals That Request 
Advisory Committee Review 
 
If a sponsor seeking resolution of a scientific and/or medical dispute requests advisory 
committee review of the matter, CDER or CBER should determine whether such review is 
appropriate and would be helpful to CDER or CBER at that time in the FDR process.  CDER or 
CBER should communicate this determination to the sponsor following the procedures described 
in section V.A., Responses to an Appeal. 
 
1.  Granting a Request for Advisory Committee Review 
 
If a sponsors request for review by an advisory committee is granted, the matter should be 
brought to the next scheduled advisory committee meeting for which there is adequate time 
available on the agenda for discussion of the issue(s).  Because of administrative concerns 
related to organizing each advisory committee meeting (e.g., establishing an agenda, sending 
background information to the advisory committee members before the meeting), it may not be 
feasible to raise the matter at the next scheduled meeting of the appropriate advisory committee.  
 
  11  Contains Nonbinding Recommendations 
As discussed in FDA regulations (21 CFR 14.5(b)) and the preamble to the final rule amending 
21 CFR 10.75,18 the advice and recommendations of an advisory committee do not bind CDER 
or CBER to a particular action or policy.  After receiving the advice of the advisory committee, 
the deciding official should provide the sponsor with an interim response or a decision within 30 
calendar days.     
 
2.  Denial of a Request for Advisory Committee Review 
 
If CDER or CBER does not grant a sponsors request for advisory committee review, CDER or 
CBER should notify the sponsor in writing of such decision, including the reason(s) for the 
denial and any steps the sponsor may take to address CDER or CBERs concerns about the 
appropriate involvement of an advisory committee.   
 
 
VI.  REPEAT APPEALS 
 
If a sponsors FDRR is denied at one management level, the sponsor can appeal the same matter 
to the next higher management level in the center chain of command.  A new FDRR should be 
submitted for each appeal to the next management level and should follow the process and 
timelines provided in this guidance.  If the sponsor has exhausted the centers management levels 
and remains unsatisfied with CDERs or CBERs decision, the sponsor may request review of 
the matter by the Commissioner of Food and Drugs (Commissioner) under 21 CFR 10.75(c).  
Requests for review by the Commissioner should be submitted to the FDAs Ombudsman, with a 
copy provided to the center that denied the appeal, as described in section IV.A., How to Request 
Formal Dispute Resolution.  Review of such matters by the Commissioner is discretionary.19   
 
 
VII.  PAPERWORK REDUCTION ACT OF 1995 
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). 
 
The time required to complete this information collection is estimated to average 8 hours for a 
sponsor to prepare and submit a request for formal dispute resolution, including the time to 
review instructions, search existing data resources, gather the data needed, and complete and 
review the information collection.  Send comments regarding this burden estimate or suggestions 
for reducing this burden to:  Office of Regulatory Policy, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD  
20993-0002. 
 
 
18 See Administrative Practices and Procedures; Internal Review of Decisions (63 FR at 63980, November 18, 
1998). 
 
19 See 40 FR 40682, 40693 (September 3, 1975).  
  12  Contains Nonbinding Recommendations 
This guidance also refers to previously approved collections of information found in FDA 
regulations.  The collections of information for Form FDA 1571 have been approved under 
OMB control number 0910-0014 and for Form FDA 356h have been approved under OMB 
control number 0910-0338. 
 
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.  The OMB control number 
for this information collection is 0910-0001.  The current expiration date is available at 
https://www.reginfo.gov (search ICR and enter OMB control number). 
 
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