Institute of Medicine Releases Report Regarding the Safety of Approved Drugs

July 13, 2010


The FDA asked the Institute of Medicine (IOM) to look at when and how to conduct clinical trials for medications which have previously been approved by the FDA.

The IOM recommended that the FDA only conduct clinical trials if: there is a significant question about public health risks of the approved drug, there is not enough existing information to assess the risks, information cannot be gained by conducting a different type of study, the trial is designed to assess the drug’s efficacy and safety, and the trial minimizes risks to study participants.

This report is only a portion of a larger study the IOM is conducting; a comprehensive report should be available in 2011

View the full report.