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 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]
Some biological products are regulated by the Center for Drug Evaluation and Research (CDER) while others are regulated by Center for Biologics Evaluation and Research (CBER).[2]
A BLA is submitted after an
After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.
See also
- New drug application
- Investigational new drug
References
- ^ "Biologics License Applications (BLA) Process (CBER)". FDA. 2015. Retrieved July 9, 2016.
- ^ "Archived copy" (PDF). Food and Drug Administration. Archived from the original (PDF) on February 3, 2017. Retrieved January 27, 2017.
{{cite web}}: CS1 maint: archived copy as title (link) - ^ Group, The FDA. "The Biologics License Application (BLA) Process Explained". www.thefdagroup.com.