FDA Proposed Rule: Sponsors Must Report Suspicions of Falsified Study Data

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A proposed FDA rule would require all “sponsors” (defined broadly) to report not only known falsification of study data but also falsifications merely suspected. The rule, “Reporting Information Regarding Falsification of Data,” defines falsification as “creating, altering, recording, or omitting data in such a way that the data does not represent what actually occurred.” The rule proposes strict timeframes for reporting. The duty to report would be undiminished even where evidence of falsification is slight.

Parties seeking to comment on the proposed rule must submit comments by May 20, 2010.

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Sheppard Mullin Richter & Hampton LLP on:

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