US FDA’s PDUFA VIII Ideas Could Include Creating Regulatory Science Research Program

With regulatory science research already funded for generic drugs and biosimilars, CDER Director Patrizia Cavazzoni wants a program for prescription drugs considered for the next user fee renewal.

Long-term planning — FDA officials already are considering ideas for PDUFA VIII, even though PDUFA VII is less than a year old. • Source: Shutterstock

The oldest user fee program at the US Food and Drug Administration could reach regulatory science research parity with its younger siblings after the next round of negotiations.

PDUFA VIII negotiations may not begin until 2025, but Center for Drug Evaluation and Research Director Patrizia Cavazzoni already envisions potentially proposing a prescription drug user fee regulatory science research...

US FDA’s PDUFA VIII Ideas Could Include Creating Regulatory Science Research Program

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