Opportunity
Federal Register #FDA-2026-N-3334
FDA Releases Annual Report on Postmarketing Requirements and Commitments for Drug and Biologics Firms
Buyer
Food and Drug Administration
Posted
April 24, 2026
Identifier
FDA-2026-N-3334
This announcement from the Food and Drug Administration (FDA) provides an overview of its annual report on postmarketing requirements and commitments for drug and biologics firms. - Government Buyer: - Department of Health and Human Services, Food and Drug Administration (FDA) - Scope of Report: - Covers all firms holding approved applications for drug and biological products - Summarizes the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) - Includes data on the number of applicants with open PMRs/PMCs, timeliness of annual status reports, and the status of studies and clinical trials - Data is combined from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research - OEMs and Vendors: - No specific OEMs or vendors are named; the report addresses all application holders in the drug and biologics sector - Products/Services Requested: - No procurement of products or services is requested in this announcement - Unique or Notable Requirements: - The report is mandated by the Federal Food, Drug, and Cosmetic Act - Provides transparency on industry compliance with postmarketing obligations - Availability: - The report is accessible on the FDA website - Locations: - FDA offices in Silver Spring, MD, are listed as the points of contact and report origin
Description
The Food and Drug Administration (FDA) announces the availability of its annual report on the performance of drug and biologics firms in conducting postmarketing requirements (PMRs) and commitments (PMCs). The report covers the status of studies and clinical trials required or agreed upon by application holders of approved drug and biological products. It summarizes data for fiscal year 2024, including the number of applicants with open PMRs/PMCs, timeliness of annual status reports, and the status of these studies. The report is available on the FDA's website.