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FDA, TGA, WADA, and USADA Warnings For searches around thymosin beta-4 FDA TGA WADA USADA warnings , the regulatory picture is consistent across agencies: TB-500 is not an FDA-approved drug, Australia's TGA lists TB-500 among unapproved peptide products with safety, quality, labeling, and import concerns, and WADA/USADA treat thymosin beta-4 derivatives such as TB-500 as prohibited for tested athletes

As a result, it is very difficult to compare in vitro/in vivo effective concentrations, as deeply discussed in Section 3 and Section 7

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Moreover, higher titres of anti-S and anti-N IgG and IgM correlate with worse clinical readouts and older age 17 , suggesting potentially detrimental effects of antibodies in some patients