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Clinical Trial Disclosure: Only ‘Tiny Fraction’ Of Thousands Of Unreported Results Cited By US FDA

Executive Summary

Yale researchers call on FDA to send more pre-notices of noncompliance to those who have not reported trial results. Of 58 pre-notices in last eight years, 56% went to pharma industry and none went to federal agencies. Commissioner-in-waiting Califf is expected to focus on trial reporting.

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