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

 
• By Derrick Gingery

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

More from User Fees

More from Pathways & Standards