1. Pink Sheet

PDUFA VII Could Expand US Real-Time Review Beyond Oncology

 
• By Derrick Gingery

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.

Real world data
The FDA has proposed creating an internal central committee to deal with real-world evidence use in decision-making. • Source: Shutterstock

US Food and Drug Administration officials are interested in testing the real-time oncology review program in other disease areas as part of the next prescription drug user fee cycle.

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