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FDA Issues Draft Guidance on Financial Disclosure by Clinical Investigators

July 2011

Regulatory Focus

On 24 May 2011, the US Food and Drug Administration (FDA) released draft guidance to replace its current guidance on disclosure of financial interests held by clinical investigators. The draft guidance reflects the changing landscape both within and outside FDA regarding transparency of financial interests. Consistent with increased public attention to physician-industry financial ties, the tenor of the draft guidance suggests that clinical trial sponsors should expect a more rigorous review by FDA of these financial arrangements. Comments on the draft guidance must be submitted by 25 July 2011. This article highlights the main changes proposed by the draft guidance that sponsors should consider as they select clinical trial investigators, design their studies and prepare the financial disclosure information to be submitted in the marketing applications to FDA.

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