Actions Taken

FDA Acts on Drug Safety Recommendation in IOM Report

Released: 8/3/2008

On June 30, 2008, the Food and Drug Administration (FDA) shifted authority on drug safety regulatory issues from the Office of New Drugs (OND) to a shared responsibility between OND and the Office of Surveillance and Epidemiology (OSE). Under the new agreement, the drug review and drug safety offices will share equal responsibility on "significant safety issues" for pending and approved products, such as post-marketing studies and clinical trials, and safety labeling changes. Joint authority among OND and OSE was recommended in the Institute of Medicine report The Future of Drug Safety: Promoting and Protecting the Health of the Public, released in September 2006.

Back