Personalized medicine and precision therapeutics are revolutionizing the healthcare landscape by tailoring medical treatments to individual patients based on their unique genetic, molecular, and clinical characteristics. This review article delves into the essential regulatory considerations that underpin the development and deployment of personalized medicine and precision therapeutics. It explores the regulatory agencies and frameworks governing this field, emphasizing the roles of entities such as the FDA and EMA. The article examines the challenges of ethical, legal, and social implications (ELSI), data privacy, and the delicate balance between innovation and safety in this evolving landscape. Key components of regulatory considerations, including biomarker development, companion diagnostics, clinical trial design, and post-market surveillance, are analyzed for their critical roles in ensuring the efficacy and safety of these novel treatments. The article concludes with an exploration of emerging technologies such as CRISPR and their regulatory implications, shedding light on potential future directions in this rapidly evolving field.
personalized medicine, precision therapeutics, regulatory considerations, FDA, EMA, biomarker development, companion diagnostics, clinical trial design, post-market surveillance, CRISPR, emerging technologies
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