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Point/Counterpoint: Combined Adcomm Briefing Document Not A Collaboration, US FDA Says

 
• By Sue Sutter

The development of a joint document is not iterative and there is no discussion between the agency and sponsor, according to new guidance seemingly aimed at differentiating the frequent use of joint backgrounders in oncology from the single document developed for the Alzheimer's drug Aduhelm.

Separation
New guidance on joint briefing documents for ODAC meetings emphasizes the concept of separate contributions from the sponsor and agency. (Shutterstock)

Joint briefing documents for the Oncologic Drugs Advisory Committee meetings are not intended to be a collaboration between the US Food and Drug Administration’s review team and the sponsor.

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