Ethics

FDA asks HHS Inspector General to investigate FDA-sponsored clinical trial

Published in Medical Letter on the CDC and FDA, April 20th, 2003

The U.S. Food and Drug Administration (FDA) has asked the Inspector General of the U.S. Department of Health and Human Services to investigate significant concerns involving a clinical trial that FDA itself sponsored.

The trial, named "Bone 97, A Dietary Strategy to Maximize Bone Mass in U.S. Naval Academy Mid-Shipmen," was funded by the Department of the Army. The principal investigator is an FDA employee, and the coprincipal investigator is employed by a private foundation.

FDA is requesting this investigation because of apparent lapses that occurred during the conduct of this study and failure to safeguard information collected as part of this...

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Source: Medical Letter on the CDC and FDA (2003-04-20)

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