US FDA’s Standard Application Assessment Makes A Comeback
After years where many more applications received priority assessments than standard assessments, in FY 2022 the difference narrowed.
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Because the Advanced Research Projects Agency for Health can reimburse FDA for services, the two agencies are discussing what that could be available, such as priority assessments, when the projects reach the application stage.
However, user fee carryover balances will not last forever and service cuts are inevitable if a shutdown lingers for several weeks.
A move to cut senior FDA positions including CDER Director through the appropriations process is rare and almost certain to fail, but experts say the attempt is indicative of an environment that seems to be encouraging these personal amendments.