• where experts go to learn about FDA
  • Month: July 2019

    • Telemedicine: Understanding FDA’s Role in Recent Regulatory and Enforcement ActionsJuly 12th, 2019

      Telemedicine platforms provide consumers and patients with convenient access to healthcare services. For this reason, the interest in and use of telemedicine services has increased significantly in recent years. While many discussions of the risks related to telemedicine focus on state laws and fraud and abuse concerns, …

    • PMA Panel Votes: More Than Meets the EyeJuly 11th, 2019

      FDA advisory panel meetings to review pre-market applications (PMAs) are high-stakes events.  While FDA is not bound by the vote of the advisory panel, it has been long-accepted that the agency typically follows the recommendation of the panel. Which got us thinking:  are conventional wisdom and …

    • Rule to Require Drug Prices in TV Ads Found InvalidJuly 9th, 2019

      On July 8, 2019, U.S. District Court Judge Amit P. Mehta struck down a recently finalized Centers for Medicare & Medicaid Services (CMS) rulethat would have required drug pricing disclosures to be included in television advertisements for certain prescription drugs and biological products (the “Price …

    • A Round Up of New State Laws to Control Drug PricesJuly 8th, 2019

      While the federal government continues to debate the hot topic of drug prices, states continue to pass new laws designed to tackle drug pricing, price reporting, and discounting.  We’ve previously reported on the laws passed in California, Connecticut, Louisiana, Maryland, Nevada, New York, Oregon, Vermont …

    • Cybersecurity Fears Lead to Insulin Pump RecallJuly 3rd, 2019

      On June 27, Medtronic announced that it was recalling certain MiniMed insulin pumps due to “potential security vulnerabilities.”  On the same day, FDA issued a Safety Communication and the Department of Homeland Security issued a Cybersecurity Infrastructure Security Advisory about the same issue. FDA’s Safety Communication …

    • Device Manufacturer’s Criminal and Civil Penalties Deserve Closer AttentionJuly 2nd, 2019

      Today’s blog post illustrates how a company’s problems can escalate rapidly from an administrative warning letter to the full weight of the criminal system.  The unfortunate subject is ACell, a manufacturer of medical devices derived from porcine urinary bladder material.  ACell received a Warning Letter …

    • HP&M’s James Valentine Named a 2019 RARE Champion of Hope; Moderates Global Rare Disease Town Hall with FDA and EMAJuly 1st, 2019

      Last week, Global Genes, a global rare disease patient advocacy organization, announced the 2019 RARE Champion of Hope Awardees, which included Hyman, Phelps & McNamara, P.C.’s very own, James Valentine.  This is a great honor, bestowed upon “true champions for rare disease”, “people who inspire …