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New Drug Application
Fierce 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
FDA cuts could put agency's user fee programs at risk: reports
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Tenpoint preps FDA filing after scoring in presbyopia study
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