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, Legal, Market Access, Regulatory, Safety, healthcare | Also tagged Abigail Alliance, breakthrough therapies, Breast cancer, Cancer, compassionate use, FDA, FDA safety and innovation act, HHS, Market Access, patient advocates, PDUFA V, policy
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 CBI, David Vance
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Patients on the Picket Line