483
Lifebridge Health, Inc. IRBLifebridge Health, Inc. IRB – FDA 483, Mar 11, 2019
Record Details
An FDA inspection of Lifebridge Health, Inc. IRB in Baltimore, MD, revealed a significant deficiency in their review process. The Institutional Review Board failed to document required determinations for studies involving children, specifically regarding compliance with 21 CFR 50 Subpart D. This indicates a lapse in ensuring additional safeguards for vulnerable populations in clinical investigations.
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ID · ee7d120e-feb2-42ea-933d-f067eeb1d895
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