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Article: FDA asks Inspector General to investigate FDA-sponsored clinical trial. (Breaking News).
- Article from:
- Biomedical Market Newsletter
- Article date:
- March 31, 2003
CopyrightCOPYRIGHT 2003 Biomedical Market Newsletter, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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MARCH 21, 2003 -- WASHINGTON DC -- The FDA today announced that it has asked the DHHS Inspector General 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 co-principal 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 research which could result in ...