"Comments from the FDA on the Drug Safety Risk Management Action Plan pose the biggest downside risk in our view, " wrote Geoffrey Meacham of J.

FORBES: The Tysabri Game Plan

In preparing for the July 2010 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, the FDA sought to provide the committee members with all available data relevant to the cardiovascular safety of rosiglitazone.

FORBES: The FDA Responds To Steve Nissen's Criticism Of Upcoming Avandia Meeting

Concerned about the entire class of COX-2 inhibitors, the FDA convened a joint session of their Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee on February 16, 17 and 18 to advise the FDA on the risk-benefit profile for these drugs.

FORBES: Vioxx and Diclofenac: Why Are Two Heart Risky Pain Drugs Viewed Differently?