US FDA Advisory Committees: Flipping FDAAA Mandate On Its Head
FDA’s use of advisory committees is at a historic low – as are the prospects of sponsors getting a positive outcome. Is it COVID? Or a more fundamental shift in how FDA uses its panels?
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The Return Of The Advisory Committee: US FDA Has Busy Fall Ahead
The prototypical US FDA advisory committee review of a pending new drug application has become something of an endangered species. A suddenly busy October and November agenda suggests that might be changing.
Will Amylyx’s ALS Drug Benefit From US FDA’s Aduhelm Experience?
A rare second advisory committee meeting is scheduled for Amylyx’s ALS drug to discuss additional analyses that the company submitted, allowing another glimpse into the FDA’s pre-decision thinking.
US FDA Advisory Committees As The Court Of Appeals
The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.