FzioMed Inc. Disagrees with Advisory Panel’s Recommendation to FDA Regarding Oxiplex® Gel
7/18/2008 9:57:03 AM
SAN LUIS OBISPO, Calif.--(BUSINESS WIRE)--FzioMed, Inc. today said that it strongly disagrees with the recommendation made July 15 by the U.S. Food and Drug Administration (FDA) Orthopaedic and Rehabilitation Devices Advisory Panel, that the Company’s Premarket Approval (PMA) application for Oxiplex gel was not approvable. The advisory panel’s action constitutes a recommendation that is not binding on the FDA. The FDA may accept or reject the recommendation, modify it, request additional information, or take no action.
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