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Regulatory Bodies Navigate Complexity to Accelerate Personalized Medicine Approvals; Balancing Innovation with Safety in a Dynamic Market
Regulatory approval processes are critical to the personalized medicine market’s growth, yet they face unique challenges. Unlike traditional drugs, personalized therapies often target rare genetic subtypes, have smaller patient cohorts, and rely on novel biomarkers—factors that complicate traditional efficacy and safety assessments. Agencies like the FDA, EMA, and China’s NMPA...
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