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The FDA's reasoning comes down to one word: need
Lau J, Bloch P, Schffer L, Pettersson I, Spetzler J, Kofoed J, et al
An intensive discussion on the pancreatic safety of incretin-based therapies initiated by publications of a single group have led to a thorough evaluation of non-clinical and clinical data by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) (3845)
doi:10.1056/NEJMoa2307563 2024 The Author(s)
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