Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

Prior to enactment of the final investigational new drug application (IND) safety reporting rule, an attempt was made to document the effort expended at investigative sites in processing IND safety reports from sponsors and to assess the effect of these expedited reports on trial conduct. Investigat...

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Detalhes bibliográficos
Publicado no:Ther Innov Regul Sci
Main Authors: Kramer, Judith M., Vock, David, Greenberg, Howard E., Janning, Cheri, Szczech, Lynda, Salgo, Miklos, Gagnon, Suzanne, Ellenberg, Susan
Formato: Artigo
Idioma:Inglês
Publicado em: SAGE Publications 2014
Assuntos:
Safety
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4230957/
https://ncbi.nlm.nih.gov/pubmed/25419504
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/2168479013520160
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