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Industry Willing To Let US FDA Go Slowly With Real-Time Review Expansion

 
• By Derrick Gingery

Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.

FDA building
Postmarket negotiations during application assessments are expected to improve by starting earlier.

Stakeholders may be excited to expand the US Food and Drug Administration’s real-time review program beyond oncology, but industry seems content with a slow roll-out during the next prescription drug user fee cycle.

The PDUFA VII agreement between industry and the FDA includes creation of the Split Real-Time Application Review (STAR) pilot program

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