FDA's Breakthrough Workload Will Be Eased By Hiring Reviewers With PDUFA VI Funds

User fees won't support dedicated staff, but rather FTEs that will work on the popular program as needed.

The solution to the breakthrough therapies program's overwhelming workload was not creating a new user fee or new requirements, but strengthening FDA's review divisions.

More than 15% of the expected new full-time equivalents that will come from the prescription drug user fee reauthorization will be rank-and-file reviewers and related staff targeted at

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