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Regulatory Bodies

Meaning

Regulatory bodies are governmental or independent agencies established to create, oversee, and enforce rules and standards for the development, manufacturing, marketing, and distribution of medical products, including pharmaceutical drugs and compounded hormonal therapies. These entities ensure product safety, efficacy, and quality control, thereby protecting public health and maintaining consumer confidence in the clinical practice environment. Key examples include the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) globally.