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