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.

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CBER wants to add and on-board the new staff as soon as feasible during PDUFA VII. • Source: Shutterstock

US Food and Drug Administration officials want user fees to fund more staff for the cell and gene therapy program.

The Center for Biologics Evaluation and Research wants additional support staff, as well as “indirect and direct review roles.” An...

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