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Eye On ODAC: Former Members, FDA’s Pazdur Talk Pre-Meeting Mindsets, Impact Of Sponsor’s Experts

 
• By Sue Sutter

Oncologic Drugs Advisory Committee reps and the Oncology Center of Excellence director go behind the scenes to discuss FDA interactions with panelists, how opinions can change during a meeting, and why the voting question is important.

Behind the curtain
Current and former ODAC members, along with OCE Director Richard Pazdur, gave a behind-the-scenes look at the adcomm experience. • Source: Shutterstock

The US Food and Drug Administration’s Richard Pazdur does not come into an Oncologic Drugs Advisory Committee meeting with his mind made up on what regulatory action the agency is going to take on a cancer drug application.

The Oncology Center of Excellence director also rarely talks to the panel chairman before a meeting

Key Takeaways

  • Going into an ODAC, FDA’s oncology review office has a tentative idea of the regulatory action it expects to take, but this can change during the meeting

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