biologics license application

(redirected from BLA)
Also found in: Dictionary, Acronyms, Wikipedia.

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 ?
M/s Advaita Holdings Private Limited is a holding company of M/s BLA Industries Limited.
BLA has revealed via filing a statement with the Thai stock exchange in August that it owns a stake of 52% in BLA (Cambodia), with $7 million in registered capital.
According to sources that arrested and eliminated suspects included members of Al Qaeda, TTP, BLA, Lyari gang war and Muttahida Qaumi Movement.
At the outset, Attorney General Mukul Rohatgi, appearing for Coal Ministry, said that Jindal Power and Steel, BLA Power and Sova Ispat Ltd have filed five separate petitions in Delhi, Madhya Pradesh and Calcutta High Courts respectively.
By definition, the Priority NMEs and New BLAs category is a subset of the All Priority NDAs and BLAs.
Prior to the meeting, Osiris submitted a comprehensive outline of the proposed content and structure of the BLA.
This BLA for DWP-450 was initiated by the company's wholly-owned subsidiary, Evolus Inc.
Tenders are invited for BLA wholeness Porumbescu - Berchisesti with demolition CED Lucacesti
The BLA spokesperson said that three officials of Balochistan Constabulary, who were in the custody of BLA have now been released unharmed, reports the Daily Times.
Malik said that BLA was a biggest enemy of the country and it was working against Pakistan.
AN accountancy firm has launched a new service - BLA Consulting - aimed at providing support and advice to businesses.
M2 EQUITYBITES-January 26, 2016-Amgen's BLA for ABP 501 accepted for review by the US FDA for chronic inflammatory conditions