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FDA FINANCIAL DISCLOSURE REG WOULD APPLY TO DATA SUBMITTED UNDER OTC MONOGRAPHS

This article was originally published in The Tan Sheet

Executive Summary

FDA FINANCIAL DISCLOSURE REG WOULD APPLY TO DATA SUBMITTED UNDER OTC MONOGRAPHS, the agency stated in a proposed role on "Financial Disclosure by Clinical Investigators," published in the Sept. 22 Federal Register. The disclosure requirements would apply to "clinical data submitted as part of the over-the-counter monograph process," FDA explained, adding that it believes data "submitted for OTC products are no less important than data submitted as part of the NDA or ANDA processes and should be treated similarly." FDA added that it will extend the proposal to foods and animal drugs in a future notice.
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