Vol , Issue Date of Publication: October 01, 2011
DOI: https://doi.org/10.20529/IJME.2011.082

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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
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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©Indian Journal of Medical Ethics 2016: Open Access and Distributed under the Creative Commons license ( CC BY-NC-ND 4.0),
which permits only non-commercial and non-modified sharing in any medium, provided the original author(s) and source are credited.

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