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US FDA gets tough on financial disclosures by clinical investigators

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration has substantially revised its guidance on the disclosure of financial interests by clinical investigators and is seeking stakeholder feedback on the draft document1,2. The revised guidance addresses concerns that the FDA does not do enough to guard against financial conflicts of interest among physicians, who carry out clinical trials of pharmaceuticals and medical devices that have yet to receive marketing authorisation.

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