US FDA’s RTOR Program Produces Approvals About One Month Sooner Than Priority Review Goal
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.
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Early approvals may not be feasible for all submissions due to specific issues with an application or overall workload considerations, FDA says in a new draft guidance on the RTOR program; agency recommends bundling components of an RTOR application in a maximum of three partial submissions and a final submission.
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.
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