Pain And Function Are Best Endpoints For Knee Cartilage Trials – FDA Panel
Joint pain and function are the most clinically meaningful efficacy outcomes and should both be used as primary endpoints for clinical trials of cellular products for treatment of knee cartilage defects, FDA's Cellular, Tissue and Gene Therapies Advisory Committee recommends
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“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
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