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.
You may also be interested in...
Other subgroups negotiating specific issues for the user fee reauthorization have indicated that agreements are close.
'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.
More patient-centric trial designs also may be coming due to pandemic-related advances, Marks says.