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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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.
As outside report urges increased planning and culture changes, FDA OTS Director Keller says recruitment will stop ‘order taking’ and move to ‘forecasting the hiring needs of each of the centers.’