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PHARMAKINETICS CITED FOR PROTOCOL VIOLATIONS IN BIO STUDIES

Executive Summary

PHARMAKINETICS CITED FOR PROTOCOL VIOLATIONS IN BIO STUDIES in a Dec. 20 warning letter sent by FDA's Division of Scientific Investigations to the Baldmore contract clinical research firm. "Your firm has violated FDA regulations in failing to follow the protocol with respect to subject inclusion/exclusion criteria, failing to document the medical basis for the discretionary inclusion of subjects who did not meet the inclusion criteria and failing to inform the IRB [institutional review board] of protocol changes," the warning letter charges.

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