FDA Proposed Rule Requires Reporting Suspected Falsification of Data in Studies with Human or Animal Subjects

April 01, 2010

The U.S. Food and Drug Administration (FDA or the Agency) recently announced a Proposed Rule titled “Reporting Information Regarding Falsification of Data” in a February 19 Federal Register Notice (75 Fed. Reg. 7,412). FDA is proposing to require makers of FDA-regulated products to report confirmed or suspected falsification of data in studies involving human or animal subjects to the Agency within 45 calendar days of becoming aware of such information. FDA is requesting general comments on the Proposed Rule and the following six specific issues.

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