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Fda regulations governing disclosure of individual

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Reference no: EM131701022

The FDA regulations governing disclosure of individual COIs require:

Researchers to annually self-disclose financial COIs to the FDA

Sponsors to annually disclose to the FDA financial COIs of researchers who conducted clinical studies

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies

Organizations to disclose financial COIs to the FDA no later than the time of submission of the IND application

Reference no: EM131701022

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