Fierce Biotech April 8, 2024
Few officials at the FDA have the same influence as Richard Pazdur, M.D. In 2023, the Oncology Center of Excellence (OCE) under his leadership doled out 83 therapeutic approvals, including 14 for new drugs. So when the FDA’s oncology czar speaks, people listen.
At the inaugural American Association for Cancer Research Oncology Industry Partnering Event, Pazdur addressed some key topics at the FDA’s oncology department, including accelerated approval and confirmatory trial requirements, advisory committee meetings, some new regulatory initiatives and even his succession plan.
As always, Pazdur’s statements—sometimes blunt and humorous while other times strategically vague—offer biopharma companies important guidance to the OCE’s practice and priorities.
Two first-of-their-kind complete response letters
The FDA a few days ago issued two...
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