Subpart C—Biologics Licensing

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

• 601.12
  § 601.12 Changes to an approved application.
• 601.14
  § 601.14 Regulatory submissions in electronic format.
• 601.15
  § 601.15 Foreign establishments and products: samples for each importation.
• 601.20
  § 601.20 Biologics licenses; issuance and conditions.
• 601.21
  § 601.21 Products under development.
• 601.22
  § 601.22 Products in short supply; initial manufacturing at other than licensed location.
• 601.27
  § 601.27 Pediatric studies.
• 601.28
  § 601.28 Annual reports of postmarketing pediatric studies.
• 601.29
  § 601.29 Guidance documents.