The US Food and Drug Administration’s Office of Prescription Drug Promotion has not cited a company for advertising violations since last June so its untitled letter to Xeris Biopharma Holdings, Inc. is notable for showing the kind of behavior that will evoke a complaint.
With First Advertising Letter In 12 Months, US FDA Goes After Xeris’s Webpage Promotion Of Recorlev
Webpages misrepresent findings in two clinical studies to overstate efficacy of the Cushing’s syndrome drug and minimize serious risks, Office of Prescription Drug Promotion says. This is second untitled letter issued to Xeris in three years.
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