biologics license application

(redirected from Biologic License Application)
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biologics license application

A 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),

BLA

A request for approval by the U.S. Food and Drug Administration of a drug made by biotechnology.
Medical Dictionary, © 2009 Farlex and Partners
References in periodicals archive ?
The North American partner of ALK-Abello, Merck, submitted the biologic license application for the tablet to the FDA in March 2013 and the FDA accepted the application for review in May 2013.
M2 EQUITYBITES-November 19, 2010-Ethicon announces submission of Biologic License Application for its Fibrin Pad to FDA(C)2010 M2 COMMUNICATIONS http://www.m2.com