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