Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter F - Biologics |
Part 601 - Licensing |
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. |
§ 601.25 - 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. |