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Adverse Event Reporting To The IRB

Law360 (February 23, 2009, 12:00 AM EST) -- Institutional Review Boards should review their written policies to determine whether they are consistent with the recommended reporting guidelines described in this new guidance for adverse event information in studies conducted under the investigational new drug regulations.

The U.S. Food and Drug Administration (FDA) regulates certain clinical investigations of drugs and biologics under sections 505(i), and of devices under 520(g), of the Federal Food, Drug and Cosmetic Act.

All such clinical studies must be reviewed and approved by an Institutional Review Board (IRB) prior to study...
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