1. Pink Sheet
  2. >>Pathways & Standards
  3. >>User Fees

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.

A pilot program called “Split Real-Time Application Review,” or STAR, would allow “split submission and review of required sections of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from User Fees

More from Pathways & Standards

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
• By Anju Ghangurde

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.