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.
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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