Puma Biotechnology is the latest victim of standing requirements in patent cases that continue to wreak havoc on plaintiffs' ability to recover a full measure of damages.
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with several notable changes.
FDA recently issued a draft guidance, Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling (link), which describes information.
On March 13, 2024, Merck Sharp & Dohme, LLC ("Merck") filed four additional IPRs challenging The Johns Hopkins University ("JHU") patents covering methods of treatment using pembrolizumab.