Vaccines, Blood & Biologics
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
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 - 406KB)
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
Contact FDA
Division of Manufacturers Assistance and Training
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-41
Rockville, MD 20852-1448