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Oncology Pilot To Highlight Disagreements Between US FDA And Sponsor For Advisory Committees

 
• By Kate Rawson

'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.

Large Battle Between Medieval Warriors. Medieval Reenactment. - Image
Hopefully the disagreements between the US FDA and oncology sponsors will be less pointed than this depiction.

The US Food & Drug Administration’s Oncology Center of Excellence is preparing an alternative approach to briefing documents for an upcoming advisory committee meeting intended to highlight key points of disagreement between the agency and the sponsor.

OCE Director Richard Pazdur announced the pilot almost offhand during remarks to the Friends of Cancer Research annual meeting on 12 November. At the time, Pazdur was providing an update on the OCE’s most recently unveiled pilot, the “Project Orbis” joint review program

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