US FDA's Biologics Center May Get Its Day In PDUFA VII
Multiple stakeholders call for CBER to receive more prescription drug user fee funds amid growing cell and gene therapy popularity.
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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.
CBER Proposes Increasing Cell, Gene Therapy Staff In PDUFA VII
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.
Full Extent Of Clinical Trial Damage May Be Unknown Until Pandemic Ends, CBER’s Peter Marks Says
More patient-centric trial designs also may be coming due to pandemic-related advances, Marks says.