1. Pink Sheet

PDUFA VII Commitment Letter Outlines Real-Time Review Expansion, Hiring Goals

 
• By Derrick Gingery

Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.

Two puzzle pieces
STAR pilot program participants can submit applications in two parts, but the second part must arrive within about two months of the first. • Source: Alamy

The successful real-time oncology review program will expand during the next prescription drug user fee program cycle, but only in a limited fashion.

US Food and Drug Administration and industry representatives agreed to create the Split Real-Time Application Review (STAR) pilot program as part of PDUFA VII, beginning in fiscal year 2023. The new

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