US FDA’s Assessment Aid May Spell The End Of Dueling Advisory Committee Briefing Packages
Pilot project allows FDA conclusions about a drug’s efficacy and safety to be integrated with, but distinguished from, a sponsor’s own analysis; though currently used for reviews of oncology applications, template could become the basis for a consolidated advisory committee briefing document.
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Tweaks to the combined advisory committee briefing document such as appendices with quality of life or other commonly requested information may be needed.
US FDA's questions about Keytruda's increased response rate in Merck's study compared to the historical control were raised in a new point-counterpoint advisory committee briefing document format.
'Point/Counterpoint' program grew out of Assessment Aid initiative in the Oncology Center of Excellence and will be unveiled at an upcoming ODAC meeting.