Tag Archives: Expanded Access Programs

CytRx Faces Partial Clinical Hold after Death in Compassionate Use Program

CytRx announced on Tuesday that FDA gave notice of a partial clinical hold for trials for its oncology candidate aldoxorubicin. The hold results from a reported death of a late-stage cancer patient “who did not qualify to participate in any of the ongoing aldoxorubicin clinical trials, but had received aldoxorubicin under the Company’s expanded access […]
Posted in FDA, Safety, Strategy | Also tagged | Leave a comment

Patients on the Picket Line

Good science can’t be rushed, even when the lives of patients hang in the balance. But regulatory science, and its relationship to a drug’s commercial success or failure, can inadvertently block access to individual patients in their hour of need.
Posted in Biotech, FDA, healthcare, Legal, Market Access, Regulatory, Safety | Also tagged , , , , , , , , , , , | Leave a comment

Evaluating Expanded Access Programs

Pharmaceutical Executive recently spoke with David Vance, Senior Director of the Compliance Counsel at Noven Pharmaceuticals, about the birth of Expanded Access Programs and the role patient advocacy groups can play in shaping those programs.
Posted in Events, People | Also tagged , | Leave a comment
  • Categories

  • Meta