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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Detalles Bibliográficos
Autores principales: Wittes, Janet, Crowe, Brenda, Chuang-Stein, Christy, Guettner, Achim, Hall, David, Jiang, Qi, Odenheimer, Daniel, Xia, H. Amy, Kramer, Judith
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2015
Materias:
Original Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4606817/
https://www.ncbi.nlm.nih.gov/pubmed/26550466
http://dx.doi.org/10.1080/19466315.2015.1043395

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4606817/
https://www.ncbi.nlm.nih.gov/pubmed/26550466
http://dx.doi.org/10.1080/19466315.2015.1043395

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