Real-time reviews for cell and gene therapies? Pfizer to FDA: Yes, please
The FDA’s Oncology Center of Excellence has a program, known as Real-Time Oncology Review (RTOR), that speeds up cancer drug approvals, sometimes by months, but has always been restricted to cancer drugs — first with supplements and then moving on to full approvals.
How RTOR works: Earlier submissions of topline efficacy and safety results from sponsors, prior to the submission of the complete application, help to support an earlier start to the FDA’s evaluation of the complete application.
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