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The Food and Drug Administration (FDA) issued its final guidance for financial disclosure by clinical investigators.  Originally effective on February 2, 1999, the Financial Disclosure by Clinical Investigators regulation (21 CFR part 54) required the applicant to certify the absence of certain financial interests and arrangements or disclose the nature of those interests and arrangements and describe steps taken to mitigate the potential for bias.
 
The new guidance requires additional submission of certain information in relation to the compensation, financial interests and arrangements of any clinical investigator conducting clinical studies for applicants submitting a marketing application for a drug or biological product or device.  An applicant must submit to the FDA a list of all clinical investigators who conducted covered clinical studies and identify full-time and part-time employees of the sponsor.  For clinical investigators not full-time or part-time employees, the applicant must provide certification (using Form FDA 3454) that certain financial interests or arrangements do not exist, or disclose the nature of those interests and arrangements and describe steps taken to mitigate the potential for bias.
 
The guidance identifies specific financial interests and arrangements that must be disclosed.  The agency may refuse to file a marketing application that does not contain the required financial information.  Further, if the FDA determines that the disclosures raise serious questions regarding the integrity of the data, the FDA will take necessary steps to ensure such reliability, including potentially initiating an agency audit, requesting further information or refusing to treat the data from the study as a basis for FDA action.

David Katz is a Senior Audit Manager providing domestic and international accounting, auditing and business consulting services to public and private clients in a variety of industries.

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