Code of Federal Regulations > Title 21 > Chapter I > Part 601 > Subpart C - Biologics Licensing

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Jul 11, 2020

§ 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.