Broadening Enforcement Of FDA Clinical Investigator Rule

Law360, New York (May 24, 2012, 1:13 PM EDT) -- Effective May 30, 2012, a clinical investigator deemed ineligible to receive one type of test article, e.g., drug, device or new animal drug, due to repeated or deliberate violations of the U.S. Food and Drug Administration’s (FDA) clinical research regulations will now be ineligible to conduct a clinical research investigation that supports an application for a research or marketing permit for other kinds of products regulated by the FDA.

In this article, we provide a brief summary of the final rule that implements this change, the...
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