21 CFR § 314.630 Applications for FDA Approval to Market a New Drug

§ 314.630 Postmarketing safety reporting.

Current through Sep 8, 2026 · Read all of Part 314

⚠ 4 pending changes to Part 314

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.

← § 314.620 Withdrawal procedures.§ 314.640 Promotional materials. →