The FDA estimates the PreCheck program could save participating companies up to 14 months by reviewing facilities while they are still under construction ...
Expedited development and review programs established by the US Food and Drug Administration (FDA) have a growing role in bringing drugs and biologics to market, with novel orphan and nonorphan ...
In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...
The Food and Drug Administration Monday announced an initiative to encourage the use of RFID by drug companies. Phillips Industries’ new Cincinnati-area distribution center is now shipping aftermarket ...
The US FDA has begun accepting applications for its pilot PreCheck program, which is designed to ease the process for pharma companies to build new manufacturing facilities in the US. The program is ...
A Democratic lawmaker is raising new concerns about an FDA program designed to drastically shorten the review of certain drugs, including whether senior officials involved in the effort are complying ...
1don MSNOpinion
FDA drug approval affects healthcare around the world, but political shortcuts could hurt the agency’s international reputation
At the beginning of July 2026, the U.S. Food and Drug Administration approved the first gene therapy for young children with ...
(RTTNews) - Galectin Therapeutics Inc. (GALT) Friday announced that the U.S. FDA has provided written feedback on its development program for Belapectin, the company's investigational galectin-3 ...
Meghana Keshavan covers biotech and contributes to The Readout newsletter. Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
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