Accelerated Approval Is For Patients, Not Sponsors – US FDA’s Pazdur

 
• By Michael McCaughan

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.

OCE protect and serve
Richard Pazdur is policing the accelerated approval pathway on behalf of patients. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

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