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FDA Should Ease Criteria For Some Renal Studies, Advisory Cmte. Says

Executive Summary

FDA should amend its new renal testing guidance to reflect real-world conditions and ease the burden - in at least one area - for sponsors, according to an FDA advisory committee. With an eye toward facilitating clinical testing, the panel recommended that the agency change its patient selection criteria for one segment of pharmacokinetics studies on the effect of renal impairment on drug dosing

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