Back to Regulatory Science at CDER
Pharmacogenomics, an important part of precision medicine, is the study of how a person’s genetic makeup can affect their response to a drug. Health care providers can use pharmacogenomic information to help decide the most appropriate treatment for each individual. Some examples include choosing a drug that is more likely to work, avoiding drugs that might have side effects, adjusting the dose of a drug, or determining if closer monitoring is needed. In addition, pharmacogenomics now plays an important role in the drug development process, opening new opportunities in drug discovery.
The Genomics and Targeted Therapy Group is located within FDA’s Office of Clinical Pharmacology and works to apply pharmacogenomics and other biomarkers in drug development and clinical practice. FDA scientists work in multiple ways to ensure that pharmacogenomic strategies are applied appropriately in all phases of drug development. Core functions include regulatory review, research, policy development, and education and outreach.
FDA reviewers evaluate the effect of genetic factors on drug safety, efficacy, or dose. They also provide advice to drug developers on how to use genomic biomarkers.
FDA conducts research projects related to pharmacogenomics and works with other scientists throughout government, academia, and industry. Research projects focus on ways to increase efficiency in drug development and apply pharmacogenomics to improve patient care.
Guidance and Policy Development
FDA works to identify emerging pharmacogenomic issues in science and drug development to develop guidance documents and scientific standards to guide the pharmaceutical industry.
Education and Outreach
FDA helps organize public workshops and conferences to bring together experts to discuss how pharmacogenomics can be used to improve drug discovery and development and advance personalized medicine.