FDA Won't Approve Wright Medical Bone Graft Application

Law360, Washington (August 9, 2013, 2:14 PM EDT) -- The U.S. Food and Drug Administration informed Wright Medical Group Inc. that its Augment Bone Graft product will not receive approval for hindfoot and ankle graft procedures, the company said Thursday.

Wright had submitted a pre-market approval application for the product, but FDA said Wright's clinical studies involved low-risk patients who may not have warranted use of the product or an autograft procedure, the company said.

The FDA told the company that it will need to conduct another clinical study with high-risk patients before the agency...
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