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Genomics at FDA

Genomics Overview

Pharmacogenomics allows us to identify sources of an individual’s profile of drug response and predict the best possible treatment option for this individual. The use of genomic information, accelerated by the sequencing of the human genome and the advent of new tools and technologies, has opened new possibilities in drug discovery and development. Consequently, regulatory science and regulations need to be set in place appropriately.

FDA recognizes the importance of pharmacogenomics and encourages its use in drug development. This is reflected in the FDA white paper “Stagnation or Innovation? – Challenge and Opportunity on the Critical Path to New Medical Products,” which identifies pharmacogenomics as a key opportunity for the Critical Path.

Several guidance documents are being developed that provide information on the Agency’s current thinking and the use of pharmacogenomics for regulatory decision making. These guidances are complemented by FDA procedural documents (e.g., MaPPs and SOPPs), which go into more detail for specific regulatory issues.

In addition, the FDA has created a new training program for genomics for review staff, organizes and participates at numerous conferences and workshops and regularly publishes new considerations and findings in the scientific literature.  The FDA also engages in several applied research projects to support and promote the translation of pharmacogenomics from basic research, drug discovery and development into clinical practice, focused on ensuring its proper employment to protect public health.

For more information on genomics, please see the 2005 FDA Consumer magazine article "Genomics and Personalized Medicine."

Contact Information

Gilbert J. Burckart, Pharm.D
Associate Director of Regulatory Policy
Acting Associate Director for Genomics
Office of Clinical Pharmacology

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Date created: March 22, 2005, updated August 14, 2008

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