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https://www.federalregister.gov/documents/2025/07/16/2025-13271/medicare-and-medicaid-prog…

… highly skilled in evaluating patients and managing clinical issues and adverse events that commonly arise during the procedure, particularly in patients with comorbid anemia, renal failure, cardiovascular disease, serum protein abnormalities or other risk factors. [ 24 ] Their k…

https://www.federalregister.gov/documents/2025/08/04/2025-14681/medicare-program-hospital-…

… instead interquartile ranges ( 90 FR 18099 ). The applicant summarized adverse events reported in Cauchy et al. (2011) and Crooks et al. (2022), as well as a multicenter retrospective cohort study and the AURLUMYN TM prescribing information. The applicant also referenced the NDA…