• Regulatory NewsRegulatory News

    FDA to Focus on Blood, Platelet Disorders at Upcoming Meeting With Patients

    US regulators have announced they will soon hold their tenth patient-focused drug development meeting, this time focusing on a collection of blood and platelet disorders that includes hemophilia A, hemophilia B, and von Willebrand disease. Background The meetings are required under the Food and Drug Administration Safety and Innovation Act (FDASIA) , Section X of which called for the US Food and Drug Administration (FDA) to meet with patients in order to better un...
  • Report: Tainted Blood Platelets Pose Greater Risk than HIV-Infected Blood Products

    There's a new top threat to the safety of the nation's blood supply.  The Wall Street Journal reports donated blood products containing bacterially contaminated blood platelets have usurped HIV for the status of the most potent threat to patients. Contaminated variants of platelets, which are used to clot blood, have been blamed in nearly two dozen deaths and hundreds of injuries in recent years. While testing is available to screen donated blood for contaminated...