Code of Federal Regulations · Section

§ 314.540 — Postmarketing Safety Reporting

21 C.F.R. § 314.540

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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.

21 C.F.R. § 314.530 21 C.F.R. § 314.550

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