21 CFR Subpart C - Subpart C—Biologics Licensing
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- § 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.