Real-Time Oncology Review Has Sponsors Rethinking What Data To Share With US FDA And When

Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular entities would bring new challenges, including need to align manufacturing and clinical site inspections with expedited review timeline.

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The US FDA’s Real-Time Oncology Review (RTOR) pilot program has required participating sponsors to change how they prepare and submit supplemental applications, but these challenges have come with some big payoffs, including greater certainty about application acceptance and review times that can be counted in days and weeks, as opposed to months.

While RTOR currently is being piloted for only the most straightforward supplemental applications, future expansion to more complex supplements or...

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