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FDA's safety page lists them under bulk drug substances nominated but withdrawn. The new briefing packet also marks the cited nominations as withdrawn, but says FDA elected to present the substances to PCAC anyway.[1][3] So three statements that sound similar mean different things: Removed from Category 2 does not mean placed in Category 1

For adult off-label use, typical daily doses often range from 0.2 mg (200 mcg) to 0.5 mg (500 mcg)

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A review published in Cureus (2024) noted that while TB-500 shows promise for soft tissue regeneration, additional research is necessary before clinical translation can occur