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of this final rule, we separately estimate the burden impacts of finalized policy provisions, and the associated updated data sources

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FDA Category 2 status AOD-9604 was previously nominated for inclusion under FDA's Category 2 list (substances proposed for compounding under research/evaluation)

Tissue Repair & Regeneration BPC-157 has been extensively studied in animal and in-vitro models for its potential to support: Muscle recovery Tendon and ligament repair Wound closure Soft-tissue remodeling 2