On March 1, 2013, the U.S. Food and Drug Administration (FDA or “the Agency”) published a final guidance entitled, “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators” (“Final Guidance”) (available here). The Final Guidance addresses compliance with the regulations governing financial disclosure by clinical investigators contained in 21 C.F.R. part 54. The guidance summarizes these regulations and then addresses specific issues in an updated question-and-answer format. The Final Guidance incorporates comments received on the 2011 draft guidance with the same title (“Draft Guidance”), and recommendations made in a 2009 report by the U.S. Department of Health and Human Services Office of Inspector General (HHS OIG).
Under 21 C.F R. part 54, applicants that submit a marketing application for a drug, device, or biological product are required to submit specific information regarding the compensation to, and financial interests and arrangements of, any clinical investigator conducting studies covered by the regulations. Applicants must disclose such interests that could affect the reliability of data submitted to FDA and identify steps taken to minimize the potential for bias, or they must certify the absence of these interests.
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