Point-Counterpoint: US FDA Adcomm Joint Briefing Document Likely Limited To Oncology For Now

 
• By Sue Sutter

Oncology Center of Excellence Director Richard Pazdur wants to make the single, joint backgrounder standard for Oncologic Drugs Advisory Committee meetings; former Peripheral and Central Nervous System Drugs adcomm member Caleb Alexander says the joint document is risky, citing the negative experience with Biogen's Aduhelm.

Debate podiums
There are differences of opinion on use of a joint FDA-sponsor briefing document for advisory committee meetings. • Source: Shutterstock

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