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    • 09 March 2019
    • Rosen Comments on FDA Commissioner’s Tenure

    • Partner David Rosen was quoted in a Modern Healthcare article, “Stakeholders anxious about FDA losing momentum after Gottlieb exits,” about the legacy of Food and Drug Administration Commissioner Dr. Scott Gottlieb, who announced his resignation last week.
    • 20 February 2019
    • Faget Comments on Likely Effects of HHS Proposal to Curb Rebates

    • Special Counsel Kyle Faget is quoted in a BioPharm Insight article, “Biosimilars, diabetes and HCV drug uptake expected to spike with HHS changes restricting safe harbor protection for PBMs and drug manufacturers, experts say,” about the expected impact of a new U.S. Department of Health and Human Services proposal to exclude rebates on prescription drugs from safe harbor protection under the anti-kickback statute.
    • 08 January 2019
    • Faget Comments on Updates to FDA’s Pre-Cert Program

    • Special Counsel Kyle Faget was quoted in a MobiHealthNews article, “FDA looks to De Novo pathway model as it unveils updates to Pre-Cert program,” about the FDA’s unveiling of new updates to its Digital Health Precertification (Pre-Cert) program.
    • 19 December 2018
    • Geilfuss, Faget Comment on Implications of Possible ACA Ruling

    • Partner Fred Geilfuss and Special Counsel Kyle Faget were quoted in a Modern Healthcare article, “ACA repeal wouldn’t stop transition to value-based payment, efforts to lower drug spending,” about what would happen if the Affordable Care Act is ultimately held to be unconstitutional.
    • 04 December 2018
    • Rosen Comments on Report That Found Flaws in FDA Drug Approval Process

    • Partner David Rosen was quoted in a Modern Healthcare article, "Federal investigation finds holes in orphan drug approval process," about an investigation by federal regulators that found fault with the U.S. Food and Drug Administration's process for approving so-called orphan drugs.
    • 19 November 2018
    • Faget Comments on FDA Proposal to Streamline Premarket Review Submissions

    • Special Counsel Kyle Faget was quoted in a MobiHealthNews article, "Proposed framework lessens FDA's regulatory requirements for prescription drugs companion apps," about an FDA proposal that would classify most software released by pharmaceutical companies as "promotional labeling" not requiring premarket review.
    • 18 October 2018
    • Beaver Comments on FDA Guidance Over Recalls

    • Partner Nathan Beaver was quoted in an Inside Health Policy article, "Food Industry Hopes FDA Is Judicious In Disclosing Retail Info In Recalls," about the FDA's recent guidance on disclosing food retailer information during certain recalls.
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