For Consumers
Cancer Specific Resources
Accelerated Approval
The committee discussed accelerated approval of drugs to treat cancer. The meeting was intended to 1) Review the status of phase IV clinical studies; (2) identify difficulties and (3) provide advice to sponsors to assist in the planning and execution of postmarketing commitments of newly approved drugs associated with completion of phase IV commitments.
March 8, 2005 Oncologic Drugs Advisory Committee Meeting
The committee discussed accelerated approval of drugs to treat cancer. The meeting was intended to 1) Review the status of phase IV clinical studies; (2) identify difficulties and (3) provide advice to sponsors to assist in the planning and execution of postmarketing commitments of newly approved drugs associated with completion of phase IV commitments.
March 12/13, 2003 Oncologic Drugs Advisory Committee Meeting
The committee discussed accelerated approval of cancer therapies
Notice of Meeting March 12-13, 2003 Final Agenda March 12-13, 2003 Final Agenda (PDF - 6KB)March 12-13, 2003 Final Agenda (DOC - 37KB)March 12-13, 2003 Draft Agenda March 12-13, 2003 Draft Agenda (DOC - 47KB)March 12, 2003 Briefing Information March 12, 2003 Slides March 12, 2003 Transcript March 12, 2003 Transcript (DOC - 341KB)March 13, 2003 Briefing Information March 13, 2003 Slides March 13, 2003 Transcript March 13, 2003 Transcript (DOC - 361KB)Concordance Index
June 7/8, 2001 Oncologic Drugs Advisory Committee Meeting
The committee discussed single patient use of non-approved oncology drugs and biologics
