biologics 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.

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.
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.
Neoprobe also filed a Biologic License Application (BLA) with the U.
The company expects to submit a Biologic License Application (BLA) to the FDA for the same product by the end of the year.
Neoprobe has completed its Phase III clinical trials and will submit its Biologic License Application (BLA) to the U.
The study was based on an analysis of 83 new drug applications and biologic license applications submitted to the U.
Cambridge, MA-based TKT will utilize CDC Solutions Professional Services for implementation, software validation, regulatory consulting, and training to facilitate publishing of electronic and paper Biologic License Applications (BLA), New Drug Applications (NDA), Common Technical Documents (CTD), and various other publications in accordance with global regulatory guidelines.
Manager of Clinical and Regulatory Affairs Documentation and a member of the TKT evaluation team said, "Our hands-on evaluation of EZsubs Enterprise allowed us to get a close look at the full scope of its bells and whistles for users, including the server-based rendering, advanced cross-referencing, and a new Submission Manager module that includes templates which provide the framework to easily publish dossiers such as Investigational New Drug Applications, and Biologic License Applications, in either paper or electronic format.
The role of the BRMAC is to make recommendations, which are not binding, to the FDA on the clinical sections of Biologic License Applications (BLAs).