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Looking For STARs: US FDA Expands Split Real Time Review Amid Low Supplement Interest

 
• By Sue Sutter

The STAR pilot established in PDUFA VII for efficacy supplements, which was modeled after the popular Real Time Oncology Review program, has not garnered much interest. The agency now is establishing a separate but similar pilot for a small number of original NDAs and BLAs.

Stars in night sky
The FDA is looking for STARs, in the form of original applications for split real time review. (Shutterstock)
Key Takeaways
  • The FDA is establishing a pilot program for split real time review of a small number of original NDAs and BLAs.

The US Food and Drug Administration is expanding the Split Real Time Application Review (STAR) approach beyond the confines of...

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