Annual Status Report Information 
and Other Submissions for 
Postmarketing Requirements and 
Commitments: Using Forms FDA 
3988 and FDA 3989 
Guidance for Industry 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
September 2023 
Food and Drug Administration Modernization Act of 1997 
 
OMB Control Nos. 0910-0001 and 0910-0338 
Current expiration date available at https://www.reginfo.gov 
(Search ICR and enter OMB control number) 
See additional PRA statement in section V of this guidance. 
   
Annual Status Report Information 
and Other Submissions for 
Postmarketing Requirements and 
Commitments: Using Forms FDA 
3988 and FDA 3989 
Guidance for Industry 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD  20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@fda.hhs.gov 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs 
 
and/or 
 
Office of Communication, Outreach, and Development  
Center for Biologics Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD  20993-0002 
Phone: 800-835-4709 or 240-402-8010; Email: ocod@fda.hhs.gov 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
September 2023 
Food and Drug Administration Modernization Act of 1997 
 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 3 
III.  FORMS FDA 3988 AND FDA 3989 ................................................................................ 5 
A.  Form FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics ................ 5 
B.  Form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics ......................... 5 
IV.  HOW TO SUBMIT FORMS FDA 3988 AND FDA 3989 ............................................. 6 
V.  PAPERWORK REDUCTION ACT OF 1995 ................................................................ 7 
GLOSSARY................................................................................................................................... 8 
 
 
  Contains Nonbinding Recommendations 
Annual Status Report Information and Other Submissions for 
Postmarketing Requirements and Commitments: Using Forms 
FDA 3988 and FDA 3989 
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 is intended for applicants that are required to report annually on the status of 
postmarketing studies and clinical trials for human drug and biological products under section 
506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356b) and its 
implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70.  In other words, this guidance 
is intended for applicants that are required by statute or regulation, or that have agreed in writing, 
to conduct postmarketing studies or clinical trials concerning a products clinical safety, clinical 
efficacy, clinical pharmacology, and nonclinical toxicology as postmarketing requirements 
(PMRs) or postmarketing commitments (PMCs).2  This guidance describes the purpose and 
content of Form FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics,3 
 
1 This guidance was prepared by the Office of New Drugs in the Center for Drug Evaluation and Research (CDER) 
in cooperation with the Office of Strategic Programs in CDER and the Center for Biologics Evaluation and Research 
(CBER) at the Food and Drug Administration.  
 
2 See section 506B of the FD&C Act; 21 CFR 314.81(b)(2)(vii) and 601.70.  FDA defines postmarketing studies or 
clinical trials for which annual status reports (ASRs) must be submitted under section 506B of the FD&C Act as 
those concerning a human drug or biological products clinical safety, clinical efficacy, clinical pharmacology, or 
nonclinical toxicology that are either required by FDA (PMRs) or that are committed to, in writing, (PMCs) either at 
the time of approval of an application or a supplement or after approval of an application or supplement.  See 21 
CFR 314.81(b)(2)(vii) and 601.70.  FDA interprets section 506B of the FD&C Act to apply to postmarketing studies 
and clinical trials that are required under section 505B of the FD&C Act (21 U.S.C. 355c), the animal efficacy rule 
(21 CFR 314.610(b)(1) and 601.91(b)(1)), accelerated approval (section 506(c)(2)(A) of the FD&C Act (21 U.S.C. 
356(c)(2)(A)); 21 CFR 314.510 and 601.41), and the Food and Drug Administration Amendments Act of 2007 
(FDAAA) (section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)).  FDAAA makes a distinction between studies 
and clinical trials.  See section 505(o)(3) of the FD&C Act.  FDA interprets the term study in section 506B of the 
FD&C Act and its implementing regulations at 21 CFR 314.81(b)(2)(vii) and 601.70 to include clinical trial.  To 
account for the distinction between studies and clinical trials in FDAAA, we refer to both studies and clinical trials 
in this guidance. 
 
3 Form FDA 3988 accompanies PMR/PMC-related submissions, excluding submissions of the ASR on PMRs and 
PMCs, as explained in section III., Forms FDA 3988 and FDA 3989, of this guidance. 
  1  Contains Nonbinding Recommendations 
and Form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics;4 when to use 
these forms; and how to submit these forms.  Submission of completed Form FDA 3989 will 
meet the annual status reporting requirements for postmarketing studies or clinical trials 
described in section 506B of the FD&C Act and its implementing regulations.5   
 
This guidance does not apply to postmarketing studies or clinical trials that are not subject to the 
reporting requirements of section 506B of the FD&C Act.6  For example, the guidance does not 
apply to voluntary studies or clinical trials conducted by an applicant or on an applicants behalf 
that are neither required nor agreed upon in writing.  This guidance also does not apply to 
chemistry, manufacturing, and controls (CMC) commitments and stability studies that are not 
subject to section 506B requirements.7 
 
The information in this guidance does not replace the information provided in the guidance for 
industry Reports on the Status of Postmarketing Study Commitments  Implementation of 
Section 130 of the Food and Drug Administration Modernization Act of 1997 (February 2006) 
and the draft guidance for industry Postmarketing Studies and Clinical Trials  Implementation 
of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (October 2019).8   
 
Forms FDA 3988 and FDA 3989 do not replace existing requirements to submit other FDA 
forms, such as the Form FDA 356h, Application to Market a New or Abbreviated New Drug or 
Biologic for Human Use, or the Form FDA 2252, Transmittal of Annual Reports for Drugs and 
Biologics for Human Use.9  Forms FDA 3988 and FDA 3989 are not intended to accompany or 
replace any submissions related to postmarketing studies or clinical trials that are not subject to 
the reporting requirements of section 506B of the FD&C Act. 
 
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.  
 
4 Forms FDA 3988 and FDA 3989, along with instructions for completing these forms, are available on the FDA 
Forms web page at https://www.fda.gov/about-fda/reports-manuals-forms/forms.   
 
5 See 21 CFR 314.81(b)(2)(vii) and 601.70. 
 
6 Under 21 CFR 314.81(b)(2)(viii), applicants submitting an annual report for human drug products must include a 
status report of postmarketing studies and clinical trials not included under 21 CFR 314.81(b)(2)(vii) that are being 
performed by, or on behalf of, the applicant.   
 
7 See 21 CFR 314.81(b)(2)(viii), which requires the applicant to advise the FDA on the status of CMC commitments 
in another section of the applicants annual report. 
 
8 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. 
 
9 FDA forms can be found on the FDA Forms web page available at https://www.fda.gov/about-fda/reports-
manuals-forms/forms.    
  2  Contains Nonbinding Recommendations 
 
 
II.  BACKGROUND 
 
Under section 506B of the FD&C Act and its implementing regulations at 21 CFR 
314.81(b)(2)(vii) and 601.70, applicants are required to provide the Agency with an annual 
report on the status of each PMR and PMC conducted to assess clinical safety, clinical efficacy, 
clinical pharmacology, or nonclinical toxicology of a human drug and biological product until 
FDA notifies the applicant, in writing, that the PMR or PMC has been fulfilled or that the PMR 
or PMC is no longer feasible or would no longer provide useful information.   
 
This annual status report (ASR) on PMRs and PMCs must include the content defined in 21 CFR 
314.81(b)(2)(vii)(a) and 601.70(b).10  This report must address the progress of the PMR or PMC 
or the reasons for failing to conduct the requirement or commitment.11  The applicant is required 
to submit the ASR within 60 days of the anniversary date of the U.S. approval of the 
application12 or an alternative date previously granted by FDA.13 
 
Applicants required to conduct postmarketing studies and clinical trials under the provisions of 
section 505(o) of the FD&C Act must also report periodically on the status of those studies and 
clinical trials.14  For a PMR issued under section 505(o)(3) of the FD&C Act, submission of the 
ASR required under section 506B of the FD&C Act and its implementing regulations (21 
CFR 314.81(b)(2)(vii) and 601.70), will satisfy the periodic reporting requirements under section 
505(o)(3)(E)(ii) of the FD&C Act if all elements required by section 505(o)(3)(E)(ii) are 
included in the ASR.15   
 
 
10 Information reported in an ASR on PMRs/PMCs includes the following: applicants name; product name (include 
the approved products established name and proprietary name, if any); new drug application (NDA), abbreviated 
new drug application (ANDA), biologics license application (BLA), and supplement number; date of U.S. approval 
of NDA, ANDA, or BLA; date of the PMR/PMC; description of the PMR/PMC; schedule for completion and 
reporting of the PMR/PMC; current status of the PMR/PMC; and explanation of the PMR/PMCs status.  See 21 
CFR 314.81(b)(2)(vii)(a) and 601.70(b). 
 
11 Section 506B(a) of the FD&C Act (21 U.S.C. 356b(a)); see the guidance for industry Reports on the Status of 
Postmarketing Study Commitments  Implementation of Section 130 of the Food and Drug Administration 
Modernization Act of 1997.  
 
12 21 CFR 314.81(b)(2) and 601.70(c). 
 
13 Applicants wishing to submit the annual report on an alternative date may submit a request in writing to FDA for 
a waiver.  See 21 CFR 314.90.  For example, an applicant may request an alternative reporting date if the applicant 
is seeking to harmonize reporting dates across international regulatory agencies or the applicant is seeking to 
harmonize reporting dates across its applications.   
 
14 Section 505(o)(3)(E)(ii) of the FD&C Act. 
 
15 To meet the requirements of 505(o)(3)(E)(ii) of the FD&C Act, for postmarketing studies and clinical trials, the 
ASR must include whether any difficulties completing the studies or clinical trials have been encountered, and for 
clinical trials, the ASR must also include whether enrollment has begun, the number of patients enrolled, the 
 
  3  Contains Nonbinding Recommendations 
Information submitted in the ASR on PMRs and PMCs is reviewed for accuracy and used by 
FDA for monitoring, tracking, and oversight of PMRs and PMCs and for maintaining FDAs 
internal databases and public web page.16   
 
Based in part on recommendations from the U.S. Government Accountability Office (GAO)17 
and the Department of Health and Human Services Office of Inspector General (OIG),18 FDA 
created Forms FDA 3988 and FDA 3989 to improve its collection, identification, and use of 
information regarding PMRs and PMCs.   
 
Applicants required to submit ASRs on PMRs and PMCs under section 506B of the FD&C Act 
and its implementing regulations (21 CFR 314.81(b)(2)(vii) and 601.70) must do so 
electronically.19  FDA does not require the use of Forms FDA 3988 and 3989, but when an 
applicant chooses to use these forms, the applicant must submit them electronically.20  FDA 
encourages applicants to use these forms to provide information concerning their PMRs and 
PMCs in a standardized format and to enhance the accuracy of data within FDAs electronic 
document archiving system.  These data are used to create PMR and PMC annual status reports 
and to update data quarterly on the FDAs Postmarket Requirements and Commitments public 
web page.21 
 
 
 
expected completion date, and registration information as required under section 402(j) of the Public Health Service 
Act (42 U.S.C. 282(j)).  Registration information for clinical trials required under section 505(o)(3) includes 
documentation that the PMR is registered in accordance with Title VIII of FDAAA.  See the guidance for sponsors, 
industry, researchers, investigators, and FDA staff Form FDA 3674  Certifications to Accompany Drug, 
Biological Product, and Device Applications/Submissions (June 2017).  
 
16 The PMR and PMC database refers to the PMR and PMC information in the electronic document tracking and 
archiving system used by CDER or CBER to capture and track all information related to all drug applications or 
licenses, including information about PMRs and PMCs.  See FDAs Postmarket Requirements and Commitments 
searchable database web page available at https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm. 
 
17 See the December 15, 2015, GAO report Drug Safety:  FDA Expedites Many Applications, but Data for 
Postapproval Oversight Need Improvement, available at https://www.gao.gov/products/GAO-16-192.   
 
18 See the July 20, 2016, OIG study FDA Is Issuing More Postmarketing Requirements, but Challenges with 
Oversight Persist, available at https://oig.hhs.gov/oei/reports/oei-01-14-00390.asp. 
 
19 Under section 745A(a) of the FD&C Act, beginning no earlier than 24 months after the issuance of a final 
guidance document in which FDA has specified the electronic format for submitting submission types that are 
covered under section 745A(a) to the Agency, such content must be submitted electronically in the format specified 
by FDA.  Section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)).  See the guidance for industry Providing 
Regulatory Submissions in Electronic Format--Certain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications (February 2020).  FDA interprets section 745A(a) to apply to the 
submission of certain investigational new drug applications (INDs), NDAs, ANDAs, and certain BLAs (excluding 
BLAs for blood and blood components, including source plasma), and all subsequent submissions including 
amendments, supplements, and reports to those submission types.   
 
20 Ibid. 
21 Available at https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm. 
 
  4  Contains Nonbinding Recommendations 
III.  FORMS FDA 3988 AND FDA 3989  
 
The following sections provide FDA guidance on when and how to use Forms FDA 3988 and 
FDA 3989.  Instructions for filling out these forms are available on the FDA Forms web page.22  
Forms FDA 3988 and FDA 3989 include predefined fields for applicants to complete.   
 
A.  Form FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and 
Biologics 
 
Form FDA 3988 includes fields for applicants to provide PMR/PMC-related information and 
should accompany each PMR/PMC-related submission except the ASR on PMRs and PMCs (see 
section III.B. of this guidance). 
 
PMR/PMC-related submissions (other than ASRs) include, but are not limited to, PMR and PMC 
draft and final protocols, interim reports, final reports, general correspondence, Pediatric 
Research Equity Act PMR deferral extension requests, responses to information requests, 
requests for revised milestones, and other PMR/PMC-related issues or correspondence.   
 
Providing complete and accurate information in this form will help expedite routing of the 
submission for FDA review and any necessary follow-up.   
 
B.  Form FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics 
 
Form FDA 3989 includes fields in which applicants should provide ASR information on their 
PMRs and PMCs.  Applicants may use the completed Form FDA 3989 to replace the content 
included in section 1.13.12, Status of Postmarketing Study Commitments and Requirements, in 
the electronic common technical document (eCTD).23  Annual submission of Form FDA 3989, 
with the appropriate fields completed, will meet the reporting requirements for postmarketing 
studies and clinical trials described in section 506B of the FD&C Act and its implementing 
regulations (21 CFR 314.81(b)(2)(vii) and 601.70).  Submission of Form FDA 3989 will also 
satisfy the periodic reporting requirements under section 505(o)(3)(E)(ii) of the FD&C Act for 
studies and clinical trials required under section 505(o)(3) of the FD&C Act, provided all 
required information is included in the submission.24  For example, to meet the requirements of 
 
22 The instructions are on the FDA Forms web page available at https://www.fda.gov/about-fda/reports-manuals-
forms/forms. 
 
23 For NDAs, completed Form 3989 replaces the section of the annual report required under 21 CFR 314.81(b)(2) 
intended for the ASR on PMRs and PMCs (21 CFR 314.81(b)(2)(vii)).  For BLAs, completed Form 3989 serves as 
the ASR on PMRs and PMCs required under 21 CFR 601.70.  Neither the ASR on PMRs and PMCs nor Form FDA 
3989 is intended to accompany or replace the annual report describing changes to a BLA submitted under 21 CFR 
601.12. 
 
24 To meet the requirements of 505(o)(3)(E)(ii) of the FD&C Act, for postmarketing studies and clinical trials, the 
ASR must include whether any difficulties completing the studies or clinical trials have been encountered, and for 
clinical trials, the ASR must also include whether enrollment has begun, the number of patients enrolled, the 
expected completion date, and registration information as required under section 402(j) of the Public Health Service 
Act.  
 
  5  Contains Nonbinding Recommendations 
505(o)(3)(E)(ii) of the FD&C Act, ASRs for clinical trials must include registration information 
as required under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).  
Registration information for clinical trials required under section 505(o)(3) includes 
documentation that the PMR is registered in accordance with Title VIII of FDAAA.  See the 
guidance for sponsors, industry, researchers, investigators, and FDA staff Form FDA 3674  
Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions 
(June 2017).  
 
 
IV.  HOW TO SUBMIT FORMS FDA 3988 AND FDA 3989 
 
As noted in section II., Background, of this guidance, use of Forms FDA 3988 and 3989 is 
optional, but when an applicant chooses to use them, they must be submitted electronically.25  
Forms FDA 3988 and FDA 3989 are fillable forms supporting electronic signatures.  FDA 
encourages use of Forms FDA 3988 and FDA 3989 because the forms allow for automated 
processing.  
 
Form FDA 3988:  This form should accompany PMR/PMC-related submissions, except the ASR 
on PMRs and PMCs required under section 506B of the FD&C Act and its implementing 
regulations (21 CFR 314.81(b)(2)(vii) and 601.70).  This form should accompany PMR/PMC-
related submissions for new drug applications (NDAs), biologics license applications (BLAs), 
investigational new drug applications (INDs), or abbreviated new drug applications (ANDAs).26  
When submitted, Form FDA 3988 should be submitted in section 1.1, Forms, in the eCTD (or to 
section 1.2, Cover Letter, if the applicants eCTD publishing tool does not have a place for Form 
FDA 3988 under section 1.1, Forms).  
 
FDA Form 3989:  When submitted, this form should be included in section 1.13.12, Status of 
Postmarketing Commitments and Requirements, in the eCTD.  The applicant choosing to use 
Form FDA 3989 should submit this form instead of adding a company-derived status update 
document in this section of eCTD module 1.  In other words, applicants should not provide both 
a company-derived ASR on PMRs and PMCs and a completed Form FDA 3989 with this section 
of the annual report. 
 
25 Under section 745A(a) of the FD&C Act, beginning no earlier than 24 months after the issuance of a final 
guidance document in which FDA has specified the electronic format for submitting submission types that are 
covered under section 745A(a) to the Agency, such content must be submitted electronically in the format specified 
by FDA.  Section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)).  See the guidance for industry Providing 
Regulatory Submissions in Electronic FormatCertain Human Pharmaceutical Product Applications and Related 
Submissions Using the eCTD Specifications.  FDA interprets section 745A(a) to apply to the submission of certain 
INDs, NDAs, ANDAs, and certain BLAs (excluding BLAs for blood and blood components, including source 
plasma), and all subsequent submissions including amendments, supplements, and reports to those submission types. 
 
26 As noted in section III.A., Form FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, of 
this guidance, Form 3988 should accompany PMR and PMC draft and final protocols.  Protocols for clinical 
investigations requiring an IND should be submitted to the appropriate IND with a copy of the cover letter to the 
NDA, ANDA, or BLA.  Protocols for clinical investigations not requiring an IND (e.g., toxicology or chemistry, 
manufacturing, and controls studies) should be submitted to the NDA, ANDA, or BLA.  See the guidance for 
industry Reports on the Status of Postmarketing Study Commitments  Implementation of Section 130 of the Food 
and Drug Administration Modernization Act of 1997.   
  6  Contains Nonbinding Recommendations 
 
Applicants must also complete and submit Form FDA 2252 when submitting Form FDA 3989.27   
 
  NDA holders completing section 9.g., Status Reports of Postmarketing Study 
Commitments, of Form FDA 2252 should refer to the accompanying Form FDA 3989. 
For example, in section 9.g. of Form FDA 2252, note that Form FDA 3989 included in 
Section 1.13.12.  
 
  BLA holders that submit Form FDA 3989 in lieu of a company-derived ASR should 
check the box in section 10.a., Annual Progress Reports of Postmarketing Studies, of 
Form FDA 2252.  
 
 
V.  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. 
3501-3521).  The time required to complete this information collection is estimated to average 1 
hour per response (per form), including the time to review instructions, search existing data 
sources, 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 
New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD  20993-0002. 
 
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 numbers for this information collection are 0910-0001 and 0910-0338.  The 
current expiration date is available at https://www.reginfo.gov (search ICR and enter 
OMB control number). 
 
 
 
 
27 21 CFR 314.81(b)(2) and 601.70(b). 
  7  Contains Nonbinding Recommendations 
GLOSSARY 
 
506B-reportable PMRs and PMCs:  Postmarketing requirements (PMRs) and postmarketing 
commitments (PMCs) are studies or clinical trials (concerning clinical safety, clinical efficacy, 
clinical pharmacology, or nonclinical toxicology) conducted by the applicant after FDA has 
approved a drug or biological product for marketing or licensing.  These studies or clinical trials 
can be either required by statute or regulation (PMRs) or agreed upon, in writing, by FDA and 
the applicant (PMCs).1   
 
Annual status reports (ASRs) on PMRs and PMCs:  A progress report submitted each year 
for applications with certain open PMRs and PMCs (concerning clinical safety, clinical efficacy, 
clinical pharmacology, or nonclinical toxicology).  New drug application holders submit the 
ASR as a section2 within the annual report required for the application under 21 CFR 
314.81(b)(2).  Biologics license application holders submit the ASR as a separate report that 
includes all the information required under 21 CFR 601.70(b).   
 
Postmarketing commitment (PMC):  Any study or clinical trial that an applicant has agreed, in 
writing, to conduct after approval of a marketing or licensing application or supplement that is 
not a PMR (see PMR definition below). 
 
Postmarketing requirement (PMR):  Any study or clinical trial that an applicant is required by 
statute or regulation to conduct after approval of a marketing or licensing application or a 
supplement.  FDA can require application holders to conduct postmarketing studies and clinical 
trials under section 505B of the FD&C Act (often referred to by the acronym of the legislation 
that created it, the Pediatric Research Equity Act or PREA),3 the animal efficacy rule,4 
accelerated approval,5 and PMRs under section 505(o)(3).6  
 
PMR/PMC schedule milestones:  The specific milestone dates set forth as part of a PMR or 
PMC for conducting and completing a PMR or PMC that must be reported annually.  The typical 
milestone dates include the following: 
  Draft protocol submission date 
  Final protocol submission date 
  Study/clinical trial completion date 
  Final report submission date 
 
 
1 See section 506B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356b); and 21 CFR 
314.81(b)(2)(vii) and 601.70. 
 
2 21 CFR 314.81(b)(2)(vii). 
 
3 Section 505B(a)(4) of the FD&C Act (21 U.S.C. 355c(a)(4)). 
 
4 21 CFR 314.610(b)(1) and 601.91(b)(1). 
 
5 Section 506(c)(2)(A) of the FD&C Act (21 U.S.C. 356(c)(2)(A)); and 21 CFR 314.510 and 601.41.  
 
6 Section 505(o)(3) of the FD&C Act (21 U.S.C. 355(o)(3)). 
  8  Contains Nonbinding Recommendations 
PMR/PMC-related submissions:  A submission sent by the applicant to address an established 
506B-reportable PMR or PMC.  Such PMR/PMC-related submissions include, but are not 
limited to, PMR or PMC draft and final protocols, interim reports, final reports, general 
correspondence, PREA PMR deferral extension requests, responses to information requests, 
requests for revised milestones, and other PMR/PMC-related issues or correspondence.  
 
PMR/PMC status definitions:7 
 
Open status categories 
 
  Pending:  The study or clinical trial has not been initiated (i.e., no subjects have been 
enrolled or animals dosed), but does not meet the criterion for delayed (i.e., the original 
projected date for initiation of patient accrual or initiation of animal dosing has not 
passed). 
 
  Ongoing:  The study or clinical trial is proceeding according to, or ahead of, the original 
schedule.  The FDA considers a study or clinical trial to be ongoing until a final report is 
submitted to the FDA, as long as the activities are proceeding according to the original 
schedule.  If patient accrual or animal dosing has started but is not complete, and the 
projected date for completion of that milestone has passed, the study or clinical trial 
should be categorized as delayed. 
 
  Delayed:  The progression of the study or clinical trial is behind the original schedule.  
Delays can occur in any phase of the study, including patient enrollment, analysis of 
study or clinical trial results, or submission of the final report to the FDA.  While the 
original schedule  not a revised schedule  serves as the basis for defining a study or 
clinical trial as delayed, each phase of the study or clinical trial will be considered in its 
own right.  If the applicant has one delayed phase but gets back on schedule during the 
next phase, the delayed status will no longer apply.8   
 
  Terminated:  The applicant ended the study or clinical trial before completion and has not 
yet submitted a final report to the FDA. 
 
  Submitted:  The applicant has concluded or terminated the study or clinical trial and has 
submitted a final report to the FDA, but FDA has not yet notified the applicant in writing 
 
7 See 21 CFR 314.81(b)(2)(vii) and 601.70.  See also the guidance for industry Reports on the Status of 
Postmarketing Study Commitments  Implementation of Section 130 of the Food and Drug Administration 
Modernization Act of 1997 (February 2006) and FDAs Postmarketing Requirements and Commitments: Status and 
Fulfillment Categories web page available at https://www.fda.gov/drugs/postmarket-requirements-and-
commitments/postmarketing-requirements-and-commitments-status-and-fulfillment-categories.   
 
8 Section 505B of the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act, 
authorizes FDA to grant an extension of deferral of pediatric assessments that are required under PREA if certain 
applicable PREA criteria for deferral are met and the applicant submits certain materials in support of the extension.  
Granting a deferral extension by FDA results in the original final report due date being replaced with the extended 
deferral date (final report due date). 
  9  Contains Nonbinding Recommendations 
that the requirement or commitment has been fulfilled or that requirement or commitment 
has been released. 
 
Closed status categories 
 
  Fulfilled:  The applicant has submitted the final report for the requirement or 
commitment, and upon review of the final report, FDA is satisfied that the applicant has 
met the terms of the requirement or commitment.  The applicant will be notified through 
written correspondence that the requirement or commitment was fulfilled. 
 
  Released:  FDA has informed the applicant in writing that it is released from its 
obligation to conduct the study or clinical trial because the study or clinical trial is no 
longer feasible or would no longer provide useful information. 
  10