FDA Details Preferred Approach To Collecting Diversity Data
In a recent guidance document, the FDA explains how trial sponsors should collect and present data on the race and ethnicity of trial participants.
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The guidance document tells sponsors to ask about ethnicity before race, and provides suggested wording. It updates a 2005 guidance.
The government collected $2.68bn from settled False Claims Act cases last year, the US Department of Justice said. Another 12 device-related cases were announced in February alone.
News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance
This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.