FDA Draft Guidance for Medical Product Communications

Posted 13 September 2017 By Alan Bergstrom

placeholder+image This article focuses on the US Food and Drug Administration's (FDA's) draft guidance as it impacts prescription drug promotion and offers examples regarding information considered consistent with labeling. It emphasizes the need for regulatory professionals to better understand and adhere to FDA's evidentiary standards by utilizing examples of the Office of Prescription Drug Promotion (OPDP), formerly Division of Drug Marketing and Communications, enforcement actions that should be considered when interpreting what is "consistent with labeling."

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Categories: Labeling, Features, FDA, Communication

Tags: Communication, Labeling

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