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A Rundown Of Real-Time Oncology Review Approvals And Pending Applications

Executive Summary

Seattle Genetics holds the award for fastest supplemental approval (11 days) and fastest new molecular entity approval (119 days) under the US FDA's RTOR program, according to the Pink Sheet's Performance Tracker.

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US FDA’s Real-Time Oncology Review Program Is No Guarantee For Early Approval

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for all submissions due to specific issues with an application or overall workload considerations, FDA says in a new draft guidance on the RTOR program; agency recommends bundling components of an RTOR application in a maximum of three partial submissions and a final submission.

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FDA’s oncology review team likes to do things its own way – and at its own hyper fast pace.

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