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

Archdeacon, Patrick; Grandinetti, Cheryl; Vega, José M; Balderson, David; Kramer, Judith M

Archdeacon, Patrick; Grandinetti, Cheryl; Vega, José M; Balderson, David; Kramer, Judith M.

Afiliación

Archdeacon P; 1 Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Grandinetti C; 1 Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Vega JM; 2 Amgen Inc, Thousand Oaks, CA, USA.
Balderson D; 2 Amgen Inc, Thousand Oaks, CA, USA.
Kramer JM; 3 Duke Translational Medicine Institute, Duke Clinical Research Institute, and Department of Medicine, Duke University School of Medicine, Durham, NC, USA.

Ther Innov Regul Sci ; 48(2): 200-207, 2014 Mar.

Article en En | MEDLINE | ID: mdl-30227498

Palabras clave

clinical trials; reporting; safety

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Guideline Idioma: En Revista: Ther Innov Regul Sci Año: 2014 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Suiza

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