Category: Regulatory/FDA

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

FDA-News (1)

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

FDA-News (1)

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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Two Recent OPDP Letters Prompted by “Bad Ad Program” Complaints

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OPDP Focuses on Misleading Opioid Claims Amid National Crisis

vaccine.News

FDA Plans Expedited Approval Path for Modified COVID-19 Vaccines