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FDA Regulatory Decision-Making

Meaning

FDA Regulatory Decision-Making is the formal, evidence-based process employed by the U.S. Food and Drug Administration to determine the safety and efficacy of pharmaceutical drugs, medical devices, and biological products, including those used in hormonal health and wellness. This systematic review assesses clinical trial data, manufacturing quality, and risk-benefit profiles before a product can be legally marketed and prescribed. The resulting decision, whether approval, denial, or a requirement for further study, establishes the clinical standard of care and public access to new therapeutic options. This rigorous process is designed to protect the public health and ensure that interventions meet stringent scientific standards.