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 ?
IRBP is in discussions with leading pharmacies to be the pharmacy manager for Remune HIV/AIDS vaccine distribution whether for expanded IND or compassionate use treatment prior to FDA approval or FDA BLA commercialization.
The Madhya Pradesh High Court, on January 29, had allowed BLA Power Ltd to take part in the process of auctioning of two coal mines -- Gotitoria ( East) and Gotitoria ( West) mine in Mahapani coalfields of Madhya Pradesh.
BLA focus will cater to industries related to paint, construction material, detergents and oil field chemicals.
Chapter 5 covers the ensuing, frustrating stalemate and reviews the state of BLA tactics, techniques, and procedures.
As such, the company is now referring to the drug as MCNA and will be registering a new trade name as it files the BLA for MCNA.
Malik said BLA has owned 299 terror attacks in the province in which more than 170 FC personnel have been martyred.
The launch of BLA Consulting presents the next natural step for the company and what it offers to the customer.
The proceeds of the bazaar (market) will be used to fund charitable activities in the UAE and Bangladesh, Syeda Mustari Quanine, the president of BLA and wife of the Bangladeshi Ambassador said.
The court also pointed out that had the Service identified the costs incurred before the BLA was signed, Square D's deduction would have been limited to costs incurred from the date of the BLA forward.
The effort and thoroughness with which our team pursued completion of the Biotest-Olympus BLA are unparalleled," said Alquest President Linda Alexander.
Agreement on the timing and content of the BLA marks an important milestone in our quest to make Prochymal the world's first fully approved stem cell therapy," said C.
According to spokesperson of the Sindh Rangers the terrorists were associated with BLA and Lyari gang wars.