Drug products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved drug products, as provided in §§ 314.80 and 314.81 .
21 CFR Part 314 · Applications for FDA Approval to Market a New Drug
§ 314.540 Postmarketing safety reporting
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 314.540
- Accelerated Approval – Expedited Program for Serious Conditions draft 5 Dec 2024
- Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application 17 Jul 2009
Amendment history
Federal Register documents that created or amended this section.
- 50 FR 7493 22 Feb 1985