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Category: Regulatory/FDA

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CDER Approves 27 Novel Drugs in First Half of 2021

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FDA at Turning Point: Kate Rawson Explains

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The Real FDA Leadership Story Is New CDER Director Dr. Patrizia Cavazzoni

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Follow-up on Accelerated Drug Approvals Is Subject of FDA Advisory Panel

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FDA Clamps Down on Company for Failing to Submit Clinical Trial Data to ClinicalTrials.gov

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HHS/FDA Withdrawing Device Exemptions Proposed by Trump Administration

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CDER Novel Drug Approvals Set Record Pace in First Quarter

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FDA Cracks Down on “FDA-registered” Device Certificate Claims

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HHS Postpones Trump-legacy SUNSET Final Rule in Wake of Lawsuit

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