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The FDA’s new PreCheck programme is aimed at facilitating the introduction of new US drug manufacturing facilities.
Under PreCheck, the FDA will communicate more frequently with pharmaceutical companies, helping them as they establish or ...
In line with the Trump administration’s goal to curb the U.S.’ reliance on overseas drug manufacturing, the FDA has deployed ...
The U.S. Food and Drug Administration on Thursday announced a new program to strengthen the domestic pharmaceutical supply chain, by facilitating construction of manufacturing sites in the United ...
Grammy-nominated recording artist GloRilla faces felony drug charges after police responded to her Georgia home following a separate report of a burglary in progress.
Authorities say rapper GloRilla was arrested on felony drug chargers after marijuana was found by deputies while they ...
Applied StemCell, an advanced therapeutics CRO/CDMO specializing in iPSCs, gene editing, and small animal models, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S ...
BURNABY, British Columbia, April 01, 2025 (GLOBE NEWSWIRE) -- Telix ARTMS, Inc. (ARTMS), a global leader in radioisotope production technologies, is pleased to announce that the drug master file (DMF) ...
GeminiBio Submits Drug Master File (DMF) to FDA GeminiBio Submits Drug Master File (DMF) to FDA PR Newswire WEST SACRAMENTO, Calif., March 13, 2025 Simplifying IND and BLA filings for cell therapy ...
Because the FDA requires detailed information about human serum as part of their Investigational New Drug (IND) applications and Biologics License Applications (BLA), the DMF from GeminiBio ...
About Drug Master Files (DMF) The DMF provides the FDA with detailed information about the facilities and processes or articles used in the manufacturing, processing, packaging and storing of VYCERIN ...