The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit ...
By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...
On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
The U.S. Food and Drug Administration on Sunday began accepting requests to participate in its PreCheck pilot program, designed to boost domestic drug supply by speeding up construction and review of ...
FDA PreCheck pilot aims to speed U.S. pharma plant construction and approvals for critical medicines with earlier feedback.
A new drug application (NDA) and a biologics license application (BLA) have been resubmitted and accepted by the FDA for ...
On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...
The FDA appointed George Tidmarsh, MD, PhD, to be the nation's top drug official in July. The Center for Drug Evaluation and Research (CDER) has since cycled through another two leaders in 5 months.
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Legal questions swirl around FDA's new expedited drug program, including who should sign off
WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...
By Maggie Fick and Michael Erman SAN FRANCISCO, Jan 26 (Reuters) - Artificial intelligence has yet to deliver on the most challenging aspect of drug development -- finding new molecules that lead to ...
The MarketWatch News Department was not involved in the creation of this content. TUSCALOOSA, Ala., Jan. 06, 2026 (GLOBE NEWSWIRE) -- PridCor Therapeutics, a clinical-stage biopharmaceutical company ...
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