biologics license application

(redirected from biological license application)

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 ?
8m in initial funding to cover the vaccine development through phase I, with potential funding of up to USD312m if BARDA exercises all options to take the vaccine to phase three trials and a biological license application filing in the United States.
CMC reviewer, division of cellular & gene therapies at FDA, will outline a product life-cycle approach for developing potency assays for a CGT product from preclinical studies to the Biological License Application (BLA)
Zostavax has been licensed in the United States for adults aged 60 years and older since 2006, and a supplemental biological license application for the 50- to 59-year age group is under review by the Food and Drug Administration.
If successful, the resulting data will provide the basis for a Biological License Application (BLA) in the U.
The company also announced that is has confirmed with the US Food and Drug Administration (FDA), receipt of the first portions of its Biological License Application (BLA) for Prochymal as part of a rolling submission.
When all FDA study requirements are achieved, MP will submit a Biological License Application (BLA) to the FDA to permit commercial sales of the products for their intended use.
8221; “Pharmacometric analyses have become an increasingly important component of New Drug Application (NDA) and Biological License Application (BLA) submissions to the US FDA to support drug approval, labelling and trial design decisions.
The FDA approved Glassia(TM)following review of Kamada's Biological License Application (BLA) submitted in May 2009.
If successful, the resulting data will provide the basis for a Biological License Application (BLA) in the US, a Marketing Approval Application (MAA) in Europe, and a marketing approval application in Saudi Arabia.
Company submits first portion of Biological License Application to FDA for review
In the field of plasma-derived drugs, LFB also filed (in late 2008) a biological license application for a new-generation, multivalent human immunoglobulin that is produced in a completely new process.

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