FDA Considers Changes To Obesity Drug Clinical Trials

Law360, Washington (March 26, 2012, 6:49 PM EDT) -- The U.S. Food and Drug Administration will reconsider its clinical trial requirements for obesity drugs this week, and may add another step to the approval process for those treatments by requiring companies to test specifically for cardiovascular risks.

The obesity drug market has been fraught with issues that have delayed or denied entry to many drug candidates due to cardiovascular risks in recent years. The drugs are usually prescribed on a short-term basis to patients with a body mass index of 30 or higher, or a...
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