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FDA shares more than 200 CRLs for now-approved drugs

All of the CRLs shared today are for drugs that have since gained approval from the agency, an HHS spokesperson told Fierce.
Gabrielle Masson 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
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CorMedix hit with another CRL in effort to get nod for DefenCath

Aug 9, 2022 10:00am