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 ?
Once signed, Bello said the new BLA may also eventually lead to the hiring of more Filipino medical workers.
The FDA accepted the BLA for the asset in January, with a likely PDUFA action date of late January 2020.
Claiming responsibility for the hotel attack, the BLA warned China to stop its 'exploitative projects in Balochistan' and not to support the 'genocide of Baloch people,' threatening further attacks.
BLA has been waging an armed struggle against Pakistan since 2004.
It will also be interesting to see what they do with the asylum application filed by alleged BLA leader Brahamdagh Bugti, and for that matter, what the Swiss do, since he is currently living it up in the picturesque and famously neutral European state.
BLA has been a security nuisance for law enforcement agencies (LEAs) of Pakistan.
'It is hoped that this designation will ensure that BLA's space to operate is minimized,' the statement read.
In the video, the BLA commander was seen surrounded by heavily armed persons wearing the same camouflage uniform as members of Majeed Brigade, also known as self-sacrificing squad of the BLA, guarded him.
Reportedly the BLA was granted a priority review in December 2018, originally targeting a six months review process.
As noted above, any 3-year or 5-year exclusivity applied to an NDA-approved biological product will end at midnight on March 20, 2020, and will not confer to the product when its NDA becomes a BLA at 12 AM on Monday morning March 23, 2020.
Seven commanders of the banned outfit of BLA including its chief have been named in the case.