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Food and Drug Administration (FDA)

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Biotech

FDA hopes AI can deliver 'rapid or instant' reviews

FDA leaders believe that AI can make a “first pass” at the nearly 500,000 pages of documents included in applications received by the agency.
Darren Incorvaia Jun 11, 2025 12:45pm
Road closed and detour signs

FDA refuses Axsome filing for former Pfizer fibromyalgia asset

Jun 9, 2025 12:27pm
Robert F Kennedy Jr US President Donald Trumps nominee for Secretary of Health and Human Services testifies during hi

At cell and gene roundtable, officials pledge to slash regulations

Jun 5, 2025 2:50pm
Frost pattern on window

FDA launces generative AI tool Elsa a month ahead of schedule

Jun 3, 2025 10:40am
Large group of people seen from above gathered together in the shape of medicine cross symbol

Trial diversity nonprofit launches with FDA, Big Pharma vets

May 21, 2025 1:38pm
Paraglider over Lake Tahoe

Marty Makary names Vinay Prasad new CBER head—Chutes & Ladders

May 9, 2025 8:30am

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