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

 
• By Sue Sutter and Bridget Silverman

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for all submissions due to specific issues with an application or overall workload considerations, FDA says in a new draft guidance on the RTOR program; agency recommends bundling components of an RTOR application in a maximum of three partial submissions and a final submission.

Early start
Under RTOR, FDA can get an early jump on reviewing a drug's efficacy and safety data. • Source: Shutterstock

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