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21 CFR 601.44

§ 601.44 Postmarketing safety reporting.

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

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21 CFR 601.44, § 601.44 Postmarketing safety reporting, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88345
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Full text

Biological products approved under this program 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.