21 CFR Subpart C
Biologics Licensing
June 25, 2020
§
601.29
Guidance documents
§
601.28
Annual reports of postmarketing pediatric studies
§
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
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