Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators." This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators. This guidance provides FDA's responses to the most frequently asked questions regarding financial disclosure by clinical investigators. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2011 and replaces the guidance entitled, "Guidance for Industry: Financial Disclosure by Clinical Investigators," dated March 2001.