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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 |
