Subpart 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.