Federal (United States) · Regulations
Subpart C — Biologics Licensing
9 sections
9 sections
- 21 C.F.R. § 601.12Changes to an approved application.
- 21 C.F.R. § 601.14Regulatory submissions in electronic format.
- 21 C.F.R. § 601.15Foreign establishments and products: samples for each importation.
- 21 C.F.R. § 601.20Biologics licenses; issuance and conditions.
- 21 C.F.R. § 601.21Products under development.
- 21 C.F.R. § 601.22Products in short supply; initial manufacturing at other than licensed location.
- 21 C.F.R. § 601.27Pediatric studies.
- 21 C.F.R. § 601.28Annual reports of postmarketing pediatric studies.
- 21 C.F.R. § 601.29Guidance documents.