21 CFR 314.630 - Postmarketing safety reporting.

Regulations last checked for updates: Feb 06, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026

View all text of Subpart I [§ 314.600 - § 314.650]

§ 314.630 - Postmarketing safety reporting.

Drug products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting requirements applicable to all approved drug products, as provided in §§ 314.80 and 314.81.

authority: 21 U.S.C. 321,331,351,352,353,355,355a,355f,356,356a,356b,356c,356e,360cc,360ddd,360ddd-1,371,374,379e,379k

source: 50 FR 7493, Feb. 22, 1985, unless otherwise noted.

cite as: 21 CFR 314.630