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FDA May Disclose Clinical Investigator Financial Data In Product Approvals

Final guidance on drug sponsors’ responsibilities for financial disclosures related to clinical investigators who participate revises definitions of due diligence and covered clinical studies from the draft published in 2011, but retains FDA’s statement that it may include such disclosures in the documents released upon product approval for marketing.

FDA’s final guidance on disclosure of potential financial conflicts of interest by clinical investigators offers sponsors some more details on how to fulfill the agency’s requests, but the document retains two serious consequences related to the disclosure process – FDA can refuse to file applications without proper disclosures, and the data itself could be released when the agency approves the drug.

The agency said the final guidance

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