Biologic License Application | definition of Biologic License Application by Medical dictionary
biologics license application (redirected from Biologic License Application)
Also found in: Acronyms
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),
A request for approval by the U.S. Food and Drug Administration of a drug made by biotechnology.
References in periodicals archive
Food and Drug Administration (FDA) a Supplemental Biologic License Application
(sBLA) for Alteplase, recombinant for use in restoring function to central venous access devices (CVADs) that have become occluded or blocked, preventing the withdrawal or infusion of vital fluids to medically ill patients.
The company is gathering data from a Phase III investigational trial for the treatment of non-Hodgkin's lymphoma and intends to file a Biologic License Application
for Bexxar by the end of 1998.
We expect to file a Biologic License Application
(BLA) shortly thereafter.
Neoprobe also filed a Biologic License Application
(BLA) with the U.