The FDA's Final Rule on Expedited Safety Reporting: Statistical Considerations

In March 2011, a Final Rule for expedited reporting of serious adverse events took effect in the United States for studies conducted under an Investigational New Drug (IND) application. In December 2012, the U.S. Food and Drug Administration (FDA) promulgated a final Guidance describing the operatio...

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Библиографические подробности
Опубликовано в: :Stat Biopharm Res
Главные авторы: Wittes, Janet, Crowe, Brenda, Chuang-Stein, Christy, Guettner, Achim, Hall, David, Jiang, Qi, Odenheimer, Daniel, Xia, H. Amy, Kramer, Judith
Формат: Artigo
Язык:Inglês
Опубликовано: Taylor & Francis 2015
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Original Articles
Online-ссылка:https://ncbi.nlm.nih.gov/pmc/articles/PMC4606817/
https://ncbi.nlm.nih.gov/pubmed/26550466
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/19466315.2015.1043395
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