Experimental Cancer Drug Access To Be Topic Of FDA Consensus Conference
Executive Summary
FDA is planning a consensus conference to discuss issues surrounding single-patient INDs and expanded access programs for unapproved oncology agents, Oncologic Drug Products Division Medical Team Leader Grant Williams, MD, told FDA's Oncologic Drugs Advisory Committee June 7.
You may also be interested in...
Iressa Expanded Access Could Have Been Designed To Bolster Efficacy
AstraZeneca's expanded access program for Iressa could have been designed to bolster efficacy data from pivotal trials, FDA Oncologic Drug Products Division Director Richard Pazdur, MD, suggested
Iressa Expanded Access Could Have Been Designed To Bolster Efficacy
AstraZeneca's expanded access program for Iressa could have been designed to bolster efficacy data from pivotal trials, FDA Oncologic Drug Products Division Director Richard Pazdur, MD, suggested
ImClone C225 Compassionate Use On Hold Pending New Manufacturing Plant
ImClone Systems will consider restarting a compassionate use program for the epidermal growth factor receptor IMC-C225 when production begins at a newly constructed manufacturing plant, CEO Samuel Waksal, MD, told the House Government Reform Committee June 20.