Alcohol Study Failed to Seek FDA Approval, Possibly Violating Federal Rules

June 12, 2018

(STAT News) – The controversy surrounding a study of whether moderate drinking might prevent cardiovascular disease isn’t over: If one interpretation of federal regulations is correct, the study may be in violation of Food and Drug Administration requirements meant to protect the health of research volunteers. STAT has learned that the study’s leaders failed to seek a form of regulatory approval intended to protect study participants and ensure they understand the possible health risks of the research.

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