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

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