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Regulatory Asymmetry

Meaning

Regulatory asymmetry refers to the existence of substantial, clinically relevant differences in the legal and procedural requirements applied to commercially approved pharmaceutical products versus those applied to compounded or over-the-counter health products, particularly within the hormonal health space. This disparity creates a landscape where commercially approved drugs undergo rigorous, standardized clinical trials, while compounded or supplement-based hormonal preparations often face less stringent oversight. It represents a significant challenge for ensuring consistent product quality and patient safety across the entire therapeutic spectrum.