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for all submissions due to specific issues with an application or overall workload considerations, FDA says in a new draft guidance on the RTOR program; agency recommends bundling components of an RTOR application in a maximum of three partial submissions and a final submission.
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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.
The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.