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Biotechnology › Drug Approvals

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

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On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more

Hogan Lovells

EMA published an assessors’ guidance document in connection with explanatory note to GVP module VII

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The European Medicines Agency (“EMA”) has released a guidance document for assessors. The guidance document is written in a questions-and-answers form. It should be read in combination with the explanatory note to GVP module...more

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