Biologics 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
References
- ^ "Biologics License Applications (BLA) Process (CBER)". FDA. 2015. Retrieved July 9, 2016.
- ^ FDA web site search results for "Biologic License Application". Accessed 07 July 2010.