| Subject: | FDA Seeks Comments on Proposed Rule - Reporting Information Regarding Falsification of Data |
| Category: | Food and Drug Administration (FDA)
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| Published: | Thu, 25 Feb 2010 - 10:00 am |
| The Food and Drug Administration (FDA) is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course of proposing, designing, performing, recording, supervising, or reviewing studies that involve human subjects or animal subjects conducted by or on behalf of a sponsor or relied on by a sponsor. Under the proposed new rule, a sponsor would... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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