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Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective
Biomarkers in Medicine
The US FDA encourages the integration of biomarkers in drug development and their appropriate use in clinical practice. It is believed that this approach will help alleviate stagnation and foster innovation in the development of new medical products, and, ultimately, lead to more personalized medicine. To facilitate the use of biomarkers in drug development and clinical practice, the FDA organized workshops, issued guidances, established a voluntary submission process, developed onlinedoi:10.2217/17520322.214.171.1245 pmid:20477416 fatcat:jnd7f5dc4vhr7ilmeiqm4kwpv4