biologics license application(redirected from BLA)
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biologics license applicationA submission to the FDA that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product. The BLA supersedes the Product License Application for biologicals licensing.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
biologics license application(bī″ŏ-loj′iks),
A request for approval by the U.S. Food and Drug Administration of a drug made by biotechnology.
Medical Dictionary, © 2009 Farlex and Partners