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  1. Development & Approval Process (CBER)

Biologics License Applications (BLA) Process (CBER)

The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:

  • Applicant information
  • Product/Manufacturing information
  • Pre-clinical studies
  • Clinical studies
  • Labeling

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Contact Point
Division of Manufacturers Assistance and Training
Office of Communication, Outreach and Development
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

(800) 835-4709
(240) 402-8020

Hours Available

Food and Drug Administration
Food and Drug Administration
White Oak Campus

10903 New Hampshire Ave
Silver Spring, MD 20993
United States


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The latest information from the Center for Biologics Evaluation and Research.


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