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Real-Time Oncology Review Excludes Applications Needing Adcomms Or New REMS

 
• By Sue Sutter

Applications no longer need to have ‘straightforward study designs’ to qualify for RTOR, but no aspect of the submission should be likely to require a longer review time, US FDA says in a final guidance on the expedited pathway.

Starry sky
Revisions to the RTOR final guidance bring eligibility criteria more in line with those of the STAR program. • Source: Shutterstock

Only relatively uncomplicated drug or biologic applications that can be quickly reviewed are suitable for the US Food and Drug Administration’s Real-Time Oncology Review program, the agency clarifies in a guidance on the expedited pathway.

To be considered for RTOR, “no aspect of the submission is likely to require a longer review time,” such as for a new Risk Evaluation and Mitigation Strategy or an...

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