US FDA Advisory Committee ‘Update’ May Result In More Meetings – And More Re-Reviews
Commissioner Robert Califf’s comments offer further context for FDA’s unprecedented decision to reconvene an advisory committee for a second review of Amylyx’ AMX0035 for ALS.
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US FDA has not had a new drug application focused advisory committee meeting in more than two months, and none are currently scheduled in 2024. After a blistering pace in the first half of 2023, FDA’s sudden slowdown in expert panels is perplexing.
The US FDA will have “a lot more advisory committees in 2023,” the head of the agency’s drug center says. The numbers back her up.
The US FDA’s use of outside expert advisory committees rebounded from historic lows in 2022 – but just barely. Will Commissioner Califf’s ‘update’ of the process finally mean more committee meetings in 2023?