21 CFR § 314.540 Applications for FDA Approval to Market a New Drug

§ 314.540 Postmarketing safety reporting.

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

⚠ 4 pending changes to Part 314

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.

← § 314.530 Withdrawal procedures.§ 314.550 Promotional materials. →