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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

The US Food & Drug Administration oncology drug review team is getting a lot of attention for cleaning up accelerate approval indications after confirmatory studies fail.

But the agency is also drawing some lines in the sand when it comes to granting Accelerated Approval in the first place. In 2021 – in the midst of a...

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