U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 27, 2025

All TitlesTitle 21Chapter IPart 601Subpart C - Subpart C—Biologics Licensing
§ 601.12 - Changes to an approved application.
§ 601.14 - Regulatory submissions in electronic format.
§ 601.15 - Foreign establishments and products: samples for each importation.
§ 601.20 - Biologics licenses; issuance and conditions.
§ 601.21 - Products under development.
§ 601.22 - Products in short supply; initial manufacturing at other than licensed location.
§ 601.27 - Pediatric studies.
§ 601.28 - Annual reports of postmarketing pediatric studies.
§ 601.29 - Guidance documents.
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