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Persistent nausea, vomiting, or constipation that doesn't improve with dose titration and lifestyle changes may resolve when switching to a medication with a different pharmacological profile
The main findings covered in this article include: FDA-approved GLP-1 benchmark with well-characterized GI side effect profile from STEP trials
And so FDA is going to need to use a different lens. Unlike FDA approval of a new drug, which requires years of clinical trials demonstrating safety and effectiveness, placement on the 503A Bulks List answers a different regulatory question
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