21 CFR 601.93

§ 601.93 Postmarketing safety reporting.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 601.93, § 601.93 Postmarketing safety reporting, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88357
Permanent ID: ys:prov:88357@1
SHA-256: abf08bc7598323f779f8aa1515386fe8cb64bb682893d7e798c917e037710a3a

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Full text

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

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.