title: Precision Medicine, Diabetes, and the U.S. Food and Drug Administration.
abstract: The U.S. Food and Drug Administration (FDA) has long sought to achieve the broader use of personalized medicine, which is better targeting of FDA-approved therapies through incorporating precise knowledge of a patient's underlying condition to therapies optimally chosen to match those needs. While some strides have been made in precision medicine-particularly in oncology and rare genetic diseases-most of the standard general medicine indications have yet to realize the benefits of precision-guided therapies. This includes those for diabetes mellitus (DM), both type 1 and type 2. Although the scientific and regulatory considerations needed to move to a more "precise" future of DM prevention and treatment differ between the two disease subsets, scientific advances in both must occur before the FDA can incorporate precision medicine into its oversight of DM drug development and approval. This article provides an overview of the regulatory expectations and challenges in realizing a future where the therapeutics for DM are informed by precise knowledge of a patient's genetics and specific phenotype.
authors.affiliation: Department of Public Health Sciences and Virginia Center for Translational and Regulatory Sciences, University of Virginia School of Medicine, Charlottesville, VA rjm7cd@virginia.edu.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Meyer
mesh_terms: D001323:Autoantibodies / Q000276:immunology; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000235:genetics / Q000276:immunology / Q000517:prevention & control; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D017277:Drug Approval; D005544:Forecasting; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use; D057285:Precision Medicine; D011322:Primary Prevention; D055502:Secondary Prevention; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001323:Autoantibodies; D007004:Hypoglycemic Agents; D007328:Insulin