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321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body." FDA's letters to the other manufacturers are similar in their complaints about why their products fall under the agency's regulatory oversight and why the companies are not allowed to market them, despite their oft-cited claims that the products, especially the triple agonists, are for research only

This Universal Foundation [685] of quality measures will focus provider attention and reduce provider burden, as well as identify disparities in care, prioritize development of interoperable, digital quality measures, allow for cross-comparisons across programs, and help identify measurement gaps