Biologic license application

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A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows:

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[1]

Biological product vs. biologic vs. biologics[edit]

At the FDA web site,[2] and literature the following variations of the term are used:

  • Biologics license application
  • Biologic license application
  • Biological license application
  • Biological product license application

Per 21 CFR 601, the official term utilized is "biologics license application.

See also[edit]