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pharmacological inhibition of CYP24A1 reduces the expression of fibrosis-associated markers [110]

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This means the FDA does not review these drugs to evaluate their safety, effectiveness, or quality before they are marketed." (Source: FDA "Compounding and the FDA: Questions and Answers".) Clinical efficacy data such as the 14.9% mean weight loss from the STEP 1 trial or the 22.5% from SURMOUNT-1 comes from studies of the FDA-approved formulations, not from compounded versions