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The committee will evaluate: Available scientific evidence on TB-500's safety profile across different patient populations Clinical evidence supporting therapeutic use for wound healing, tissue repair, and recovery Public comments from patients, physicians, and pharmacies with real-world experience Quality control and compounding considerations specific to TB-500 formulations Whether TB-500 meets the criteria for inclusion on the 503A compounding list TB-500 vs
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A diagnosis of hEDS is made clinically using the 2017 diagnostic criteria
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