• where experts go to learn about FDA
    • Updated CLIA Waiver Guidances Lack Details in Original DraftJanuary 14th, 2019

      In the midst of the government shutdown and with its accompanying lull in new FDA documents, we thought it would be a good time to update our readers on some guidances that were issued late last year.  Two such notable draft guidances were the, “Select …

    • FDA Solicits Feedback on Grace Period Timing for GUDID SubmissionsJanuary 11th, 2019

      On December 18, 2018, FDA opened a docket for public comment regarding its intention to shorten the grace period for Global Unique Device Identification Database (GUDID) submissions from thirty days to seven days.  The grace period starts when Device Identified (DI) information is first entered …

    • A Pair of FDC Act-Related Convictions Upheld on Appeal in the Eighth and Eleventh CircuitsJanuary 10th, 2019

      In two unrelated cases, two U.S. Courts of Appeal affirmed FDC Act-related convictions earlier this week.  In United States v. Patino, the Eighth Circuit held that it was not an abuse of discretion to allow the government to introduce, in connection with a 2016 prosecution …

    • HP&M Releases 2018 Litigation BriefingJanuary 9th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …

    • Does the 510(k) Program Need Predicate Modernization?January 8th, 2019

      The 510(k) program is based on substantial equivalence.  A 510(k) submitter wishing to market a new device must establish that it is as safe and effective as a legally marketed device that has already received clearance.  The baseline comparison device is known as a “predicate …

    • Congratulations to HPM’s Newest Director, Allyson MullenJanuary 7th, 2019

      Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce Allyson B. Mullen has become its newest Director.  Allyson joined HPM in June 2013.  Since that time, her years of service have made significant contributions to the firm and its clients. Prior to joining HPM, Allyson served …

    • Breakthrough Designation Guidance FinalizedJanuary 7th, 2019

      On December 18, 2018, FDA issued a final guidance document on the Breakthrough Devices Program created by the 21st Century Cures Act.  The Breakthrough Device Program is meant to speed access to new devices that treat or diagnose “life-threatening or irreversibly debilitating diseases or conditions.”  …

    • Coming Soon for Expanded Access PoliciesJanuary 4th, 2019

      Many companies with investigational drugs have posted an expanded access policy on their websites as required, but more than a few still have this task left over from the 2018 to-do list.  As the time for New Year’s resolutions and new to-do lists is upon …

    • Avalanche or Roadblock: FDA Publishes Flurries of Biologic and Biosimilar MaterialsJanuary 3rd, 2019

      At the end of a calendar year in DC, we expect to see a few flurries. Maybe some light snow, but definitely flurries of regulatory activity.  December is often rich with FDA publications, specifically warning letters and guidance documents.  And things have not changed this …

    • Federal Court Invalidates CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B DrugsJanuary 1st, 2019

      On December 27, 2018, the Federal District Court for the District of Columbia enjoined the Centers for Medicare and Medicaid Services (CMS) from implementing a regulation setting reimbursement for hospital outpatient payment rates for 340B drugs at Average Sales Price (ASP) minus 22.5%. A brief history: …