FDA Issues Draft Guidance for Clinical Investigators, Industry and FDA Staff: Financial Disclosure by Clinical Investigators


The Food and Drug Administration (FDA) issued draft guidance on May 24 describing its current thinking on the disclosure of financial interests of clinical investigators1 updating the prior decade-old guidance issued on the subject. The new draft guidance is notable in that it provides more information regarding the sponsor’s responsibility to collect the required disclosure information, provides more information about the due diligence expected of an applicant in collecting the information required in a marketing application, and provides detail regarding how FDA will review and perhaps disclose the financial information it receives. Electronic or written comments on the draft guidance should be submitted by July 25, 2011.

Sponsor’s Collection of Required Disclosure Information

The draft guidance notes that the sponsor of a covered study is in a unique position to both obtain the financial information that may be needed if or when the study is submitted years later. Furthermore, the financial information collected may serve to alert the sponsor of potential conflicts of interest and thus allow it to minimize any potential for study bias. Under the regulations, any clinical investigator who is not a full-time or part-time employee of the study sponsor must provide the sponsor with sufficient and accurate financial information to allow for complete disclosure or certification and to update the financial information if any relevant changes occur either during the study or for one year after its completion.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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