The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 34th iteration – is scheduled to take place from September 18-19, 2019 at The Bostonian Hotel, Boston, MA. The conference is billed as the premier event to provide folks with a roadmap …
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, …
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 …
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 …
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 …
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 …
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 …
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 …
