New Drug Application

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Pharma

How a government shutdown will affect the FDA

Despite the FDA's plan to keep many functions running during the shutdown, new applications that require payment of a user fee won't be accepted.
Fraiser Kansteiner Oct 1, 2025 11:29am
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FDA shares more than 200 CRLs for now-approved drugs

Jul 10, 2025 10:54am
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FDA hopes AI can deliver 'rapid or instant' reviews

Jun 11, 2025 12:45pm
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FDA cuts could put agency's user fee programs at risk: reports

Apr 4, 2025 11:00am
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Tenpoint preps FDA filing after scoring in presbyopia study

Jan 9, 2025 3:39pm
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Regulatory tracker: Bayer adds new Kerendia CV outcomes nod

Aug 29, 2022 9:48am