Code of Federal Regulations · Section
§ 601.44 — Postmarketing Safety Reporting
21 C.F.R. § 601.44
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Biological products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.
Authorizing Statute
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Regulations42 U.S.C. § 216
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Definitions; generally21 U.S.C. § 321
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New drugs21 U.S.C. § 355