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Clinical-trial results cited here apply only to those branded formulations not to compounded preparations.

FDAs 2025 Increase in Warning Letters on Compounded Drug Advertising In recent remarks at the Food and Drug Law Institutes Enforcement, Litigation, and Compliance Conference, the director of the Office of Compliance within FDAs Center for Drug Evaluation and Research's (CDER) noted that 22% of warning letters that CDER issued in fiscal year (FY) 2025 were sent to telehealth platforms and other entities related to claims made regarding compounded drug products, including compounded GLP-1s