Code of Federal Regulations · Section
§ 601.8 — Publication Of Revocation
21 C.F.R. § 601.8
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The Commissioner, following revocation of a biologics license under 21 CFR 601.5(b), will publish a notice in the Federal Register with a statement of the specific grounds for the revocation.
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