Year-End Push To Meet FDAAA Puts 14 Advisory Committee Meetings On Tap
This article was originally published in The Tan Sheet
Executive Summary
The Center for Drug Evaluation and Research will hold more than twice the typical number of advisory committee meetings in November and December this year - capping off a significant overall increase in panels convened in 2008
You may also be interested in...
FDA Using More Temporary Advisory Committee Members To Fill Vacancies
FDA advisory committees are increasingly relying on temporary members to fill their ranks - a trend that could result in less predictability for drug sponsors at a make-or-break review meeting
Another Chance For VALID? Negative Reaction To FDA’s LDT Proposal May Reopen Legislative Talks
All of the witnesses testifying to a House E&C Committee hearing said they preferred the flexibility and targeted enforcement of the VALID Act to FDA’s proposed rule. Will Congress finally be spurred to act?
US FDA Advisory Panels May Look Different Across Centers, Despite Efforts To Standardize Process
As FDA is readying to go back to in-person advisory committee meetings this fall, the centers have different ideas about how to use their expert panels.