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FDA financial disclosure threshold of $25,000 in payments to investigators set in final rule.

This article was originally published in The Rose Sheet

Executive Summary

FDA FINANCIAL DISCLOSURE PAYMENT THRESHOLD RAISED FOR INVESTIGATORS to $25,000, according to the agency's final rule on financial disclosure requirements by sponsors of clinical trials of payments to or equity investments held by clinical investigators; the final rule was published in the Feb. 2 Federal Register. "Significant payments...means payments made by the sponsor of a covered study to the investigator or the institution to support activities of the investigator that have a monetary value of more than $25,000, exclusive of the costs of conducting the clinical study or other clinical studies...during the time the clinical investigator is carrying out the study and for one year following the completion of the study," the final rule states.
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