Biologic license application

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

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

• New drug application (FDA)

References