Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

In September 2010, the US Food and Drug Administration (FDA) published a final rule governing the requirements for expedited safety reporting for products subject to an investigational new drug application. The rule clarified the types of safety information that qualify for expedited reporting. Its...

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Detalles Bibliográficos
Autores principales: Archdeacon, Patrick, Grandinetti, Cheryl, Vega, José M., Balderson, David, Kramer, Judith M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2013
Materias:
Safety
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6038022/
https://www.ncbi.nlm.nih.gov/pubmed/30227498
http://dx.doi.org/10.1177/2168479013509382

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