Code of Federal Regulations · Subpart

Subpart C — Biologics Licensing

21 C.F.R. pt. 601, subpt. C

• § 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
• § 601.28 Annual Reports Of Postmarketing Pediatric Studies
• § 601.29 Guidance Documents