To Join Or Not To Join: The Challenges Of A Joint FDA-Sponsor Adcomm Briefing Document

3D Communications’ Nathan Gede says challenges related to submission timing, length and review format explain why sponsors may be reluctant to agree to a “point-counterpoint” style advisory committee briefing document, despite the Oncology Center of Excellence’s move in that direction.

Point-counterpoint
The point-counterpoint format is currently an option for advisory committee sponsors. • Source: Shutterstock

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