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for all submissions due to specific issues with an application or overall workload considerations, FDA says in a new draft guidance on the RTOR program; agency recommends bundling components of an RTOR application in a maximum of three partial submissions and a final submission.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

Early approval, or even approval, under the US Food and Drug Administration’s Real-Time Oncology Review program is not guaranteed, despite an impressive record to date of application successes.

Acceptance into the RTOR program does not guarantee or influence approval of an application and does not alter review performance...

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