Biologics Licensing Application

Biologics Licensing Application

An application to the FDA by a drug sponsor for a license to market a new biological product in the United States.
References in periodicals archive ?
The SPA process allows for a written agreement between NeoPharm and the FDA on the design of a study, including clinical drug supply, pivotal trial design, clinical endpoints, study conduct, data analysis, and other clinical trial issues, and is intended to provide assurance that if pre-specified trial results are achieved, they may serve as the primary basis for an efficacy claim in support of a Biologics Licensing Application (BLA) by the Company for IL13-PE38QQR.
Under the terms of this new collaborative agreement Seikagaku will share in IDEC's costs related to the clinical development of IDEC-152 through the filing of a Biologics Licensing Application.
The Complaints allege that defendants' false and misleading statements concerning XOMA's intent to file its Biologics Licensing Application with the Food and Drug Administration for the drug Xanelim artificially inflated the price of the stock.

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