Super-speedy cancer drug reviews: FDA unveils new draft guidance to help sponsors apply
How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? That’s where the Real-Time Oncology Review comes in.
For the last five years, FDA’s Oncology Center of Excellence under Rick Pazdur has been quietly tapped into RTOR to allow sponsors to provide even earlier, segmented submissions of critical efficacy and safety data, thereby enabling these faster evaluations of applications.
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