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Merck, ODAC Mostly Like US FDA's Point-Counterpoint Briefing Document

 
• By Derrick Gingery

Tweaks to the combined advisory committee briefing document such as appendices with quality of life or other commonly requested information may be needed.

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The point-counterpoint format is intent on reducing duplication in US FDA advisory committee briefing documents. • Source: Shutterstock

The initial reviews of the US Food and Drug Administration's remodel of the advisory committee briefing document seemed largely favorable, although there were calls to include more information in some cases.

The agency debuted what it called the point-counterpoint briefing document for the 17 December Oncologic Drugs Advisory Committee meeting on Merck & Co. Inc.'s Keytruda (pembrolizumab). Merck is...

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