Citation

Jones JK. Clin. Pharmacol. Ther. 2007; 81(2): 156-158.

Affiliation

The Degge Group, Ltd., Drug Safety, Arlington, Virginia, USA. jkjones@deggegroup.com

Copyright

(Copyright © 2007, American Society for Clinical Pharmacology and Therapeutics, Publisher Nature Publishing Group)

DOI

10.1038/sj.clpt.6100086

PMID

17259940

Abstract

In September 2004, controversy surrounded the Food and Drug Administration (FDA). It climaxed more than a decade of safety concerns involving legitimate and perceived problems with FDA-approved drugs. In response, the FDA's Center for Drug Evaluation and Research (CDER) asked the Institute of Medicine (IOM) to examine the current systems for ensuring drug safety and recommend specific actions and improvements.

Language: en