Crunch time for FDA user fees as reauthorization looks to hitch a ride on short-term spending bill
The lifeblood of the FDA’s drug reviews — the user fees that industry pays FDA for timely reviews of new and generic drugs over five-year periods — must be reauthorized before the end of this month or else reviews and approvals will grind to a halt quickly, with thousands laid off at the agency.
While the FDA says it’s expecting a deal to get done, what’s exactly in that deal remains to be seen, as sources said they haven’t seen any bill text yet, and Republicans have sought a bill clean of all riders, including one that would reform the accelerated approval pathway, linked to another short-term government spending bill.
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