SUBPART C—Biologics Licensing (§601.12 to §601.29)
- 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.
- 601.25—Review procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use.
- 601.26—Reclassification procedures to determine that licensed biological products are safe, effective, and not misbranded under prescribed, recommended, or suggested conditions of use.
- 601.27—Pediatric studies.
- 601.28—Annual reports of postmarketing pediatric studies.
- 601.29—Guidance documents.