FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007-2013

In 2002, Congress mandated that the US Food and Drug Administration (FDA) monitor postmarketing pediatric adverse events and present safety reports to the FDA's Pediatric Advisory Committee (PAC). These safety reviews play a critical role in the postmarketing surveillance and identification of...

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Veröffentlicht in:	Pediatrics (Evanston) 2015-12, Vol.136 (6), p.1125-1131
Hauptverfasser:	Cope, Judith U, Rosenthal, Geoffrey L, Weinel, Pamela, Odegaard, Amy, Murphy, Dianne M
Format:	Artikel
Sprache:	eng
Schlagworte:	Adolescent Advisory Committees Biological Products Child Child, Preschool Children Company business management Descriptive labeling Drug-Related Side Effects and Adverse Reactions - epidemiology Drug-Related Side Effects and Adverse Reactions - prevention & control Government agencies Health aspects Humans Management Patient Safety Pediatrics Pharmaceutical Preparations Product Surveillance, Postmarketing - methods Product Surveillance, Postmarketing - statistics & numerical data United States United States Food and Drug Administration Vaccines
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