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Category: Regulatory/FDA
05/06/2021
Follow-up on Accelerated Drug Approvals Is Subject of FDA Advisory Panel
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05/03/2021
FDA Clamps Down on Company for Failing to Submit Clinical Trial Data to ClinicalTrials.gov
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04/19/2021
HHS/FDA Withdrawing Device Exemptions Proposed by Trump Administration
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04/05/2021
CDER Novel Drug Approvals Set Record Pace in First Quarter
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03/29/2021
FDA Cracks Down on “FDA-registered” Device Certificate Claims
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03/22/2021
HHS Postpones Trump-legacy SUNSET Final Rule in Wake of Lawsuit
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03/15/2021
Two Recent OPDP Letters Prompted by “Bad Ad Program” Complaints
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02/23/2021
OPDP Focuses on Misleading Opioid Claims Amid National Crisis
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02/08/2021
FDA Plans Expedited Approval Path for Modified COVID-19 Vaccines
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