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US FDA’s RTOR Program Produces Approvals About One Month Sooner Than Priority Review Goal

 
• By Bridget Silverman

Novel agents approved under Real-Time Oncology Review posted a median time to approval of seven months, our Pink Sheet RTOR infographic shows, while other RTOR applications had a median 4.5 month approval time.

FDA review times
• Source: Nielsen Hobbs; the Pink Sheet | Shutterstock, Getty images

The headlines about extremely fast approval times for products using the FDA’s Real-Time Oncology Review (RTOR) pathway have faded now that the expedited review program is settling into its fifth year, but a Pink Sheet analysis found that RTOR products still reach approval in less time than the Prescription Drug User Fee Act allots to priority review applications.

For supplemental applications, the initial target of the RTOR program, the real-time review benefit works out to a savings of about 45 days: a median time to approval of 4

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