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Given the comprehensive de-identification of all data elements and the impossibility of linking results to individual patients, this study qualified for exemption from individual informed consent requirements under 45 CFR 46.104(d)(4)

Long term SURMOUNT 1 extension data

New medicines entering the German market must submit benefit-assessment dossiers to the Gemeinsamer Bundesausschuss (G-BA) [5] under the procedure established in SGB V 35a [2]

doi: 10.1016/j.pan.2018.05.002 [DOI] [PubMed] [Google Scholar] 44

Weight loss studies have demonstrated that tirzepatide effectively reduces liver fat, helping prevent or reverse fatty liver disease

Application fee : A drug's sponsor (usually the manufacturer) must pay a fee for the FDA review each time it submits an NDA, a supplemental application for a major change to an already approved NDA, or a biologics license application (BLA)