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OA Structural Progression Effect Size Of 50% Is "High Hurdle," PhRMA Says

Executive Summary

FDA's proposal that an osteoarthritis "delay in structural progression" claim be supported by a greater than 50% slowing of joint space narrowing is "too high a hurdle given the state of OA science," the Pharmaceutical Research & Manufacturers of America said in Sept. 14 comments on FDA's draft OA guidance.

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