PDUFA VII: US FDA Wants Dedicated RMAT Program Funding
Executive Summary
Cell and gene therapy product activities also have increased CBER’s workload significantly and strained staff, the agency tells industry representatives.
You may also be interested in...
PDUFA VII Could Expand US Real-Time Review Beyond Oncology
A proposed pilot program would offer for “split submission and review” of some application sections in other disease areas. Discussions also touch on concept of a CDER-CBER RWE committee.
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.