Published: December 06, 2018
Mark S. Lowenthal, Christina M. Jones, Joan Adamo, Robert Bienvenu, Owen Fields, Soma Ghosh, Michael Liebman, Robert Schuck, Scott Steele
Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps.
Citation: Journal of Clinical and Translational Science
Pub Type: Journals
Precision Medicine, Regulatory Science, Omics, US Food and Drug Administration, Clinical and Translational Science Award
Created December 06, 2018, Updated March 18, 2019