Healthy Skepticism Library item: 12539

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Galson SK.
The FDA and the IOM report.
N Engl J Med 2007 Dec 13; 357:(24):2520-1
http://www.ncbi.nlm.nih.gov/pubmed/18077820

Abstract:

“In her Perspective article on the response of the Food and Drug Administration (FDA) to a report by the Institute of Medicine (IOM) on the U.S. drug-safety system, Weiss Smith (Sept. 6 issue)1 presents an unfair and uninformed portrayal of the FDA’s commitment to drug safety and the many ways the agency is implementing major changes to further improve its drugsafety approach.

The FDA commissioned the IOM report, takes the report very seriously, and developed a comprehensive action plan on the basis of the report…”

Keywords:
Drug Approval/legislation & jurisprudence Drug Approval/organization & administration* Drug Toxicity Government Regulation Humans Institute of Medicine (U.S.)* Pharmaceutical Preparations/adverse effects Risk Assessment United States United States Food and Drug Administration*