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 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.
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.
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.