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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

Most Center for Drug Evaluation and Research offices outside of oncology are likely to stick with separate FDA and sponsor briefing documents for advisory committees rather than a single joint document that the cancer review divisions have embraced, Office of New Drugs Director Peter Stein said at the Biopharma Congress on 26 February.

In 2019, the Oncology Center of Excellence began piloting a “point-counterpoint” briefing document in which the sponsor and agency separately...

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