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 .
21 CFR Part 314 · Applications for FDA Approval to Market a New Drug
§ 314.630 Postmarketing safety reporting
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FDA guidance that cites § 314.630
- Product Development Under the Animal Rule 2 Oct 2015
Amendment history
Federal Register documents that created or amended this section.
- 50 FR 7493 22 Feb 1985