PDUFA VII: US FDA Wants Dedicated RMAT Program Funding

 
• By Derrick Gingery

Cell and gene therapy product activities also have increased CBER’s workload significantly and strained staff, the agency tells industry representatives.

Gene Therapy for Cancer Treatment Concept Cancer therapy with T-cell and pipette and vials - Image
The increased cell and gene therapy workload forced CBER staff to limit sponsor interactions and convert live meetings to "written responses only" status. • Source: Shutterstock

The Regenerative Medicine Advanced Therapy (RMAT) designation could gain dedicated funding as part of cell and gene therapy program enhancements in the US Food and Drug Administration’s prescription drug user fee reauthorization.

Minutes of a 29 September virtual PDUFA VII CBER subgroup negotiating session indicate the agency proposed dedicated resources for cell and gene therapies “to ensure long-term program sustainability.”

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