Accelerated approval reforms make the cut in year-end government spending bill
Congressional negotiators have decided to include reforms to the FDA’s accelerated approval pathway in its year-end spending package after the agency’s top leaders called for tighter controls on confirmatory trials and an easier process for withdrawing dangling accelerated approvals that failed their confirmatory trials.
The text of the bill, known as the omnibus, had been floated earlier this summer but it was unclear what it might attach to. Now, the AA reforms, released late last night, appear to be ready for showtime, stipulating that moving forward, FDA “may require, as appropriate, a [confirmatory] study or studies to be underway prior to approval, or within a specified time period after the date of approval.”
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