Pain Relief Too Subjective For Spinal Implant Studies, Groups Tell Panel
This article was originally published in The Gray Sheet
Pain relief is a subjective clinical outcome and should not be considered by FDA as a primary endpoint in clinical trial guidance for spinal fusion devices, representatives of the North American Spine Society, the American Association of Neurological Surgery, and industry unanimously told members of FDA's Orthopedic and Rehabilitation Devices Panel at an Oct. 8 meeting in Rockville, Maryland.
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