21 CFR § 601.44 Licensing

§ 601.44 Postmarketing safety reporting.

Current through Sep 8, 2026 · Read all of Part 601

⚠ 2 pending changes to Part 601

Biological products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.

← § 601.43 Withdrawal procedures.§ 601.45 Promotional materials. →