Vaccines, Blood & Biologics
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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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Key Resources
Biologic Forms Vaccine Product Approval Process Questions and Answers Regarding the Complete Response Letter Rule Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions 12/12/2007 Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction 12/26/2007 Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requireme (PDF - 866KB)
FDA Form 3674Federal Register Notice: New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule 5/31/2002 (aka Animal Rule) Lot Distribution Data (LDD) Electronic Submission U.S. Food and Drug Administration Statement: The impact of February’s inclement weather on Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) deadlines
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