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February 18, 2026
Approximately 5 minutes
FDA Postmarketing Requirements and Commitments for Drugs and Biologics
FDA Postmarketing Requirements and Commitments for Drugs and Biologics
1. Introduction
Postmarketing requirements and commitments refer to studies and clinical trials conducted after approval to gather additional information about a product's safety, efficacy, or optimal use. Some are required under statutes or regulations, while others are commitments agreed upon by sponsors. The FDA provides a searchable database for these for drugs and biological products. Source: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarketing-requirements-and-commitments-introduction
2. Search Databases
Users can search FDA's databases for postmarketing requirements and commitments for human drugs, as well as post-approval studies for medical devices. Source: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarketing-requirements-and-commitments-introduction
3. Types of Required Studies or Clinical Trials
Current requirements include those under the 2007 Food and Drug Administration Amendments Act (FDAAA) to assess known serious risks, signals of serious risks, or unexpected serious risks. Pre-FDAAA requirements cover accelerated approvals, deferred pediatric studies under PREA, and products under the Animal Efficacy Rule. Source: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarketing-requirements-and-commitments-introduction
4. Changes Since FDAAA
FDAAA introduced distinctions between required postmarketing requirements (PMRs) and committed postmarketing commitments (PMCs). The database and FAQs have been updated to reflect these changes. Source: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarketing-requirements-and-commitments-introduction
5. Additional Resources
FAQs provide further guidance on these requirements and commitments. Source: https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarketing-requirements-and-commitments-introduction
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