Biologics Licensing

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Biologics
  6. Licensing
  7. Biologics Licensing

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Section
601.12

Changes to an approved application.

Section
601.14

Regulatory submissions in electronic format.

Section
601.15

Foreign establishments and products: samples for each importation.

Section
601.20

Biologics licenses; issuance and conditions.

Section
601.21

Products under development.

Section
601.22

Products in short supply; initial manufacturing at other than licensed location.

Section
601.27

Pediatric studies.

Section
601.28

Annual reports of postmarketing pediatric studies.

Section
601.29

Guidance documents.