Title

  • FDA Responds to Institute of Medicine Drug Safety Recommendations--In Part

Creator

Published In

Date

  • 2007

Volume

  • 297

Bibliographic Citation

  • 297 Journal of the American Medical Association 1917 (2007)

Abstract

  • The withdrawal of rofecoxib in September 2004 and the reports of health risks associated with several other drugs have raised questions about the integrity of the US drug safety system. In response, and at the request of the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA), the Institute of Medicine (IOM) issued a comprehensive review and set of recommendations for reforms. The FDA has taken the unusual step of providing a detailed, public response. The FDA's new initiatives and its responsiveness to the IOM report represent incremental progress that offers insights into FDA's culture and perhaps glimpses at the future of drug safety.

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Keywords

  • FDA drug approval post-market surveillance pharmaceuticals administrative agencies

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