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In terms of specific regional regulatory practices, the United States defines EV-based products as biologics, requiring submission through the Investigational New Drug (IND) application process and undergoing rigorous preclinical and quality control reviews by the US Food and Drug Administration (USFDA) [167]

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DAO, diamine oxidase

Meta-analysis of the risk of venous thrombosis in individuals with antiphospholipid antibodies without underlying autoimmune disease or previous thrombosis