U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. Development & Approval Process (CBER)
  4. Biologics License Applications (BLA) Process (CBER)
  1. Vaccines, Blood & Biologics

Biologics License Applications (BLA) 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

Key Resources

 

Resources for You
Recalls & Alerts
Approvals & Clearances

Sub-Topic Paragraphs

Title
Follow CBER


Subscribe for CBER Updates

Get e-mail updates on What’s New at CBER!