A recent report issued by the OIG calls into question the adequacy of the FDA's oversight of financial interests of clinical investigators.
The OIG recommends that the FDA should ensure that sponsors submit complete financial information for all clinical investigators, ensure that reviewers consistently review financial information and take action in response to the disclosed financial interests, and require sponsors to submit financial information for clinical investigators as part of the pretrial process.
To read the full report and recommendations, as well as the FDA's response, please click here.
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