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Personalized Medicine Regulation

Meaning

Personalized Medicine Regulation encompasses the legal, ethical, and clinical frameworks governing the development, validation, and deployment of medical treatments and diagnostic tools tailored to an individual’s unique genetic, environmental, and lifestyle characteristics. This regulatory domain is complex, aiming to balance the imperative for rapid innovation in precision health with the need to ensure patient safety, data privacy, and clinical efficacy. It specifically addresses the challenges of standardizing individualized therapies, such as customized hormone replacement or nutrigenomic recommendations, which often fall outside traditional, one-size-fits-all drug approval pathways.