Financial Disclosure by Clinical Investigators; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES

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The Food and Drug Administration (FDA) is proposing to require that the sponsor of any drug, biological product, or device submit certain information concerning the compensation to, and financial interests of, any clinical investigator conducting clinical studies to determine whether that product meets the marketing requirements specified by the agency. This requirement will apply to most clinical studies involving human subjects, as well as any study to establish bioavailability or bioequivalence. The agency is proposing to require that sponsors certify to the absence of certain financial interests of clinical investigators or disclose those financial interests when clinical studies are submitted to FDA in support of product marketing. If the agency adopts this proposal, and the sponsor does not include one of the required submissions with the application for marketing a covered product that contains clinical data, the agency will refuse to file the application. FDA will propose to extend these requirements to submissions for marketing approval related to human foods, animal foods, and animal drugs in a notice to be published in a subsequent issue of the Federal Register. FDA is s