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We note, consistent with the discussion in the FY 2003 IPPS final rule (67 FR 50015), that while FDA has regulatory responsibility for decisions related to marketing authorization (for example, approval, clearance, etc.), we do not rely upon FDA criteria in our evaluation of substantial clinical improvement for purposes of determining what services and technologies qualify for new technology add-on payments under Medicare

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[DOI] [PMC free article] [PubMed] [Google Scholar] 66.Waitumbi J.N., Donvito B., Kisserli A., Cohen J.H., Stoute J.A

Some products reference specific peptide compounds such as collagen peptides, BPC-157, or analogues of glucagon-like peptide-1 (GLP-1) the same hormone class targeted by licensed prescription medicines such as semaglutide (Wegovy) and liraglutide (Saxenda)

Mechanisms of epithelial immunity evasion by respiratory bacterial pathogens