Accelerated Approval Is For Patients, Not Sponsors – US FDA’s Pazdur
Biotech sponsors understandably discuss accelerated approval as an important consideration in development plans. But the head of the US FDA oncology program has a reminder for them: the pathway is intended to serve patients – not drug companies.
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There is a greater commitment among larger, well-capitalized oncology companies to complete confirmatory trials, Oncology Center of Excellence Director Richard Pazdur says; smaller company approach of first getting accelerated approval and then using commercial proceeds to capitalize confirmatory trial is ‘unacceptable.’
Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.
A senior official at China’s National Medical Products Administration recently disclosed that the agency was moving to "rigorously" prevent the accelerated approval pathway from becoming distorted.