John Smith, M.D.

John Smith, M.D.

Hogan Lovells

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Latest Posts › Federal Food Drug and Cosmetic Act (FFDCA)

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CDRH issues final rule on appeals, excluding De Novos from 517A

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two accompanying guidance documents related to...more

7/10/2019  /  Administrative Appeals , FDA De Novo Clearance , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Medical Devices , Rulemaking Process

FDA proposes rule to codify existing guidance on supervisory review of CDRH decisions

On January 17, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule to update the framework for requesting internal agency supervisory review of certain decisions related to devices regulated...more

2/1/2018  /  Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Standard of Review
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