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A study of warning letters issued to clinical investigators and institutional review boards by the United States Food and Drug Administration

NJ Gogtay, BM Doshi, U Thatte

DOI: 10.20529/IJME.2011.082


Abstract

Background: Warning letters (WLs) issued by the US FDA (United States Food and Drug Administration) mention the nature of violations by clinical investigators and institutional review boards (IRBS) and can help as training tools.

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