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  • kenholmes59 kenholmes59 Jan 4, 2012 10:45 AM Flag

    FDA goes AGAINST the panel vote

    It was surprising to me that the FDA cast its lot with the naysayers on the panel, especially considering the orthopedic surgeons were supportive of Augment. Surely the FDA could of approved the product with conditions, as any safety concerns were either minor or theoretical.

    As to the CT radiological review, the FDA is requiring both re-reads and double-reads. This triple review for the sake of evaluating the "robustness" of the data is outrageous, especially if this is not common FDA practice. It appears to be a fishing expedition!