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    • 29 December 2017
    • Beaver Addresses FDA’s Planned New Guidance for Drug Developers

    • Partner Nathan Beaver was quoted in a BNA Health Care Blog article, ”FDA to Provide Earlier, Better Advice to Drug Developers,” about the FDA’s efforts to enhance its communications with drug suppliers as a way of lowering the cost of drug development.
    • 05 December 2017
    • Rosen Comments on Proposed New FDA Guidance on Drug-Device Combination Products

    • Partner David Rosen is quoted in a Health Care on Bloomberg Law article, “FDA Seeks to Speed Approvals of Generic Drug-Device Combos,” about proposed new FDA guidance that will make it easier for generic companies to get drug-device combination products approved.
    • 28 November 2017
    • Rosen Comments on FDA Commissioner’s Remarks

    • Partner David Rosen is quoted in a Pink Sheet article, “Gottlieb’s Complex Generics Remarks Could Signal (Some) Increased Flexibility,” about FDA Commissioner Scott Gottlieb’s remarks on generic copies of products with drug and device constituent parts at an internal FDA event for agency scientists and researchers.
    • 25 July 2017
    • Rosen Comments on Implications of Delay on Passing FDARA

    • Partner David Rosen told Pink Sheet in an article, “FDA Gives Congress Reprieve on Deadline for Passing User Fee Bill,” that most Senators are still pushing to get the FDA Reauthorization Act done prior to October 1, 2017.
    • 14 July 2017
    • Rosen Comments on FDA User Fee Legislation

    • In Modern Healthcare’s article, “House Passes Bipartisan FDA User Fee Bill,” Partner David Rosen discussed the impact of new legislation passed in the House of Representatives that reauthorizes the FDA’s ability to collect user fees from drug and device makers.
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