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Scott Kaplan

ID: 1b830fa4-2619-30fb-68c4

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Unclaimed

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Organization: Hogan Lovells

Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated primarily as a drug

Focus on Regulation · November 1, 2019

FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough Therapies Undergoing Expedited Approval

Focus on Regulation · August 5, 2019

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