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FDA FINANCIAL DISCLOSURE REG WOULD NOT APPLY TO PRECLINICAL

This article was originally published in The Gray Sheet

Executive Summary

FDA FINANCIAL DISCLOSURE REG WOULD NOT APPLY TO PRECLINICAL or manufacturing and controls studies, according to the agency's proposed rule, "Financial Disclosure by Clinical Investigators," published in the Federal Register Sept. 22. "FDA has tentatively chosen not to seek information on investigators carrying out preclinical or manufacturing and controls operations," the notice states.
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