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'The Pazdur Effect': A Tale Of Three US FDA Oncology Advisory Committee Meetings

 
• By Kate Rawson

ODAC meetings are usually few and far between – and rarely come with good news for the sponsor. Below are some lessons learned from the bounty (three!) held this week.

Richard Pazdur

The US Food and Drug Administration's Oncologic Drugs Advisory Committee is always fodder for interesting discussion, given that any application that Oncology Center of Excellence Director Rick Pazdur brings to committee comes with valuable “lessons learned” – not only for the sponsor under the spotlight, but for anyone else that follows.

And those lessons are not just for oncology drug developers: The newly named Office of Oncologic Diseases (which Pazdur also heads in an acting capacity) is known for being out in front on regulatory policy, and is often the recipient of envious comments from sponsors in other therapeutic areas,

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• By Bridget Silverman

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