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Home Library Publishing About

Philip Katz

ID:LEX-AR-BC08VWYV

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Unclaimed

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Organization: Hogan Lovells

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

Focus on Regulation · August 5, 2019

FDA guidance may ease path to biosimilar interchangeability

Focus on Regulation · May 15, 2019

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

Focus on Regulation · May 10, 2019

FDA’s Bendeka decision reverses approvals of Treanda generics

Focus on Regulation · February 21, 2019

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

Focus on Regulation · February 8, 2019

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