US FDA Hiring Metrics Sought To Determine PDUFA VII Changes
Other subgroups negotiating specific issues for the user fee reauthorization have indicated that agreements are close.
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FDA is only mentioned once in the document, and its temporary leadership may not be the reason why.
User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
Cell and gene therapy product activities also have increased CBER’s workload significantly and strained staff, the agency tells industry representatives.