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Regulatory Pathway

Meaning

A Regulatory Pathway, in the clinical and pharmaceutical domain, refers to the established, legally mandated sequence of steps, requirements, and submissions that a new drug, medical device, or biological product must successfully complete to gain approval for marketing and clinical use from a governing body like the FDA. This rigorous process is meticulously designed to ensure the product’s fundamental safety, demonstrable efficacy, and consistent quality before it is made available to the public. Understanding the specific regulatory pathway is an essential prerequisite for the clinical translation and application of novel hormonal therapies.