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Financial Disclosure August 19, 2011

Posted by Michael Hamrell in Regulatory Thoughts.
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In May 2011 the FDA issued an updated draft “Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators”.  This document is a revision of the original  Guidance for Industry: Financial Disclosure by Clinical Investigators dated March 2001. This revised guidance addresses issues raised by the Office of the Inspector General (OIG), Department of Health and Human Services in its 2009 report, as well as questions FDA has received from industry and the public.

The regulation has been in place since February 1999 and applies to clinical studies submitted in a marketing application that the applicant or FDA relies on to establish that the product is effective, and any study in which a single investigator makes a significant contribution to the demonstration of safety.  This includes drugs, device, biologic products subject to premarket approval or authorization including ANDAs and 510(K) submissions.  The Financial Disclosure by Clinical Investigators regulation (21 CFR Part 54) requires applicants who submit a marketing application for a drug, biological product or device to submit certain information concerning the compensation to, and financial interests and arrangements of, any clinical investigator conducting clinical studies covered by the regulation.

The new Draft Guidance provides background information on the requirements of the regulation and what is a disclosable interest.  There is also additional information provided in the form of questions and answers that addresses many of the common aspects of the regulation.  In particular, the guidance document describes FDA’s renewed focus in reviewing the disclosures provided by the clinical investigator and documentation of this during a BiMo site inspection.  The FDA indicates that failure to provide the required disclosures or adequate evidence of efforts to obtain the information could lead to FDA to refuse to file and consider a marketing application.