The Greatest FDA Advisory Committees, Part II: The Birth Of The ‘Pazdur Moment’
Executive Summary
With landmark advisory committee meetings coming up, we take a look back at some of the memorable panel meetings over the last 20 years. This is Part II in the series.
You may also be interested in...
‘Dangling’ Accelerated Approval Reviews Expand At US FDA
The oncologic drugs advisory committee’s upcoming reviews are moving beyond the PD-1/PDL-1 inhibitor class – and to a very different type of sponsor.
Hurry Up and Wait: The Slowdown in Accelerated Approvals
Accelerated approvals are decelerating. Sponsors argue the FDA is so caught up in the current emphasis on safety that they're raising the AA efficacy standards. The FDA contends that the companies who have been rejected aren't meeting the efficacy standards or performing the promised follow-up trials. Is the FDA changing the rules-or are companies themselves bending them? A look at several recent cases of AA therapies reveals that both are true.
Ilex Clolar Advisory Committee Splits On Pediatric Leukemia Approvals
FDA's Oncologic Drugs Advisory Committee recommended accelerated approval for Ilex' Clolar (clofarabine) in the treatment of pediatric acute lymphoblastic leukemia, but not pediatric acute myelogenous leukemia, at its Dec. 1 meeting