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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

Efficacy is only one part of the decision If the main question is average weight-loss effect, tirzepatide has generally shown greater average weight reduction than semaglutide in obesity-focused clinical research

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In this case, change the needle and give another dose

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