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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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.
Beginning confirmatory trials before the accelerated approval is granted shortens the time between clearance and the confirmation of benefit, when patients are at risk, said Oncology Center of Excellence Director Richard Pazdur.
The CRL follows a negative FDA advisory committee vote in September. The company will lay off three-quarters of its R&D force, but sees potential to partner or sell the asset.