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    • 15 May 2018
    • Rosen Comments on Proposed Changes in FDA Drug-Device Rules

    • Partner David Rosen is quoted in a Bloomberg Law article, “Drug-Device Rules Could Give FDA Leg Up in Industry Fights,” about the FDA’s plan to revamp its rules on how to deal with overlapping drug, device and biologic products.
    • 05 April 2018
    • Beaver Addresses Effect of New DOJ Policy on FDA Enforcement Actions

    • Partner Nate Beaver was quoted in an article for Food Quality & Safety, “What DOJ’s Policy on FDA Guidance Really Means,” about the impact that a new Justice Department policy prohibiting government litigators in civil cases from using noncompliance with guidance documents to prove violations of federal law will have on FDA enforcement actions.
    • 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.
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