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A favorable list decision can occur without the evidence package required for approval of a specific manufactured drug
Investigators also collected serial blood samples to track shifts in lipids, C-reactive protein, and liver enzymes, providing a broader picture of metabolic health
Follow-up testing at 6-8 weeks and 12-16 weeks allows monitoring of metabolic parameters and ensures the peptide is not producing unexpected effects
Whatever the committee recommends will shape what is legally available to patients for the next several years
BMJ Case Rep
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