FDA Postmarketing Requirements and Commitments Reports Overview

1. Overview

Postmarketing requirements and commitments are studies and clinical trials conducted after FDA approval to gather additional safety, efficacy, or optimal use data for drugs and biologics. FDA publishes annual notices in the Federal Register summarizing performance on these PMRs and PMCs, tracking statuses relative to original schedules. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-reports

2. Annual Report in the Federal Register

The Food and Drug Administration Modernization Act of 1997 requires FDA to publish annually in the Federal Register information on postmarket studies and clinical trials required or requested from manufacturers. These reports summarize data from FDA's internal databases, reflecting statuses like pending, ongoing, submitted, delayed, fulfilled, released, or terminated. Reports combine data from CDER and CBER, and numbers may differ from backlog reviews or public databases due to tracking evolution. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-reports

3. Annual Federal Register Notices

• FY 2023: Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: https://www.govinfo.gov/content/pkg/FR-2025-05-30/pdf/2025-09771.pdf FY 2023 Report (PDF - 261 KB)
• FY 2022: Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: https://www.govinfo.gov/content/pkg/FR-2024-04-23/pdf/2024-08649.pdf FY 2022 Report (PDF - 255 KB)
• FY 2021: Report on the Performance of Drugs and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: https://www.govinfo.gov/content/pkg/FR-2023-02-02/pdf/2023-02156.pdf FY 2021 Report (PDF - 254 KB)
• FY 2020: Updated version includes corrected BLA data in Table 7. Source: https://public-inspection.federalregister.gov/2022-08499.pdf FY 2020 Report (PDF - 466 KB)
• FY 2019: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: https://www.federalregister.gov/documents/2020/08/06/2020-17113/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-requirements-and FY 2019 Report
• FY 2018: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: https://www.federalregister.gov/documents/2019/08/07/2019-16878/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-requirements-and FY 2018 Report (PDF - 228 KB)
• FY 2017: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: https://www.federalregister.gov/documents/2018/11/19/2018-25128/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-requirements-and FY 2017 Report (PDF - 130 KB)
• FY 2016: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: https://www.federalregister.gov/documents/2017/12/08/2017-26470/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-requirements-and
• FY 2015: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: https://www.federalregister.gov/d/2016-28442
• FY 2013 and FY 2014: Combined notice due to CDER evaluation in 2013-2014 updating PMR/PMC statuses. Source: https://www.federalregister.gov/d/2016-26247 Supplementary Report: Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements (PMRs) and Postmarketing Commitments (PMCs): FY 2013 and FY 2014 (PDF - 900KB)
• FY 2012: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: http://www.gpo.gov/fdsys/pkg/FR-2014-02-18/html/2014-03353.htm PDF - 213KB
• FY 2011: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: http://www.gpo.gov/fdsys/pkg/FR-2012-03-06/html/2012-5302.htm PDF - 112KB
• FY 2010: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: http://www.gpo.gov/fdsys/pkg/FR-2011-08-04/html/2011-19806.htm PDF - 201KB -- Correction Notice Source: http://www.gpo.gov/fdsys/pkg/FR-2011-08-23/html/2011-21487.htm PDF - 181 KB
• FY 2007: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments. Source: http://www.gpo.gov/fdsys/pkg/FR-2008-04-24/html/E8-9007.htm PDF - 57KB
• FY 2006 (as of 9/30/2006): Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies. Source: https://www.federalregister.gov/documents/2007/02/02/E7-1749/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-commitment-studies
• FY 2005 (as of 9/30/2005): Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies. Source: https://www.federalregister.gov/documents/2006/03/03/E6-3019/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-commitment-studies PDF
• FY 2004 (as of 9/30/2004): Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies. Source: https://www.federalregister.gov/documents/2005/02/18/05-3221/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-commitment-studies PDF
• FY 2003 (as of 9/30/2003): Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies. Source: https://www.federalregister.gov/documents/2004/03/15/04-5757/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-commitment-studies PDF
• FY 2002 (as of 9/30/2002): Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies. Source: https://www.federalregister.gov/documents/2003/05/21/03-12720/report-on-the-performance-of-drug-and-biologics-firms-in-conducting-postmarketing-commitment-studies PDF: FR-2003-05-21 03-12720 PDF: FR-2007-02-02 E7-1749

4. Annual Report to Congress on the Backlog of PMRs and PMCs

Section 921 of FDAAA requires FDA to annually review the backlog of postmarketing safety commitments as of September 27, 2007, report to Congress on determinations, and assign dates. The backlog includes all open PMRs and PMCs at FDAAA enactment. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-reports

5. Impact of the Backlog Reviews

FDA contracted Booz Allen Hamilton for the first and second backlog reviews. Initially, 63% pending, 15% ongoing, 14% submitted, 7% delayed. After first review, accurate statuses: 14% pending, 14% ongoing, 36% submitted, 15% delayed, 14% fulfilled, 3% released, 1% terminated. Reports show steady completion, reducing open items as final reports are submitted and reviewed. Source: https://www.fda.gov/drugs/postmarketing-requirements-and-commitments-introduction/postmarketing-requirements-and-commitments-reports

6. Backlog Reports to Congress

• Sixteenth Annual Backlog Report to Congress (PDF - 483 KB) Source: /media/185134/download?attachment
• Fifteenth Annual Backlog Report to Congress (PDF - 571 KB) Source: /media/179430/download?attachment
• Fourteenth Annual Backlog Report to Congress (PDF - 447KB) Source: /media/165051/download?attachment
• Thirteenth Annual Backlog Report to Congress Source: /media/154