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Scott Kaplan
ID:
1b830fa4-2619-30fb-68c4
/
Unclaimed
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Organization:
Hogan Lovells
Published Works
2 articles
Another step forward in digital health: FDA issues draft guidance for drug master files (DMFs) for electronics and software components of combination products regulated primarily as a drug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
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FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough Therapies Undergoing Expedited Approval
Focus on Regulation ·
August 5, 2019
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