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FDA Regulations

Meaning

FDA Regulations represent the mandatory compliance frameworks established by the U.S. Food and Drug Administration governing the safety, efficacy, and quality of pharmaceuticals, biologics, and medical devices used in clinical practice. For hormonal therapies, these rules dictate clinical trial standards and labeling requirements. Adherence ensures that interventions provided to patients meet a baseline scientific and manufacturing standard. Deviation from these standards introduces unacceptable clinical risk.