Drugs
Pharmacogenomics Education Initiatives
The FDA has organized various workshops (see Upcoming Events for future workshops and Publications for proceedings from past workshops) with PhRMA, BIO and other organizations designed to both educate and provide feedback on pharmacogenomics. In addition, a number of articles have been published, encouraging a broad public education in pharmacogenomics and personalized medicine.
A new lecture series entitled “Pharmacogenomics from the Ground Up” designed for scientists with diverse academic and professional backgrounds is being held regularly and has been integrated into the ongoing education for reviewers within CDER. So far, the course is set up in three sessions
- Concepts and Tools in Pharmacogenomics [PDF]
- Submissions and Labels in Regulatory Pharmacogenomics [PDF]
- Final training on ArrayTrack, an integrated genomics analysis tool developed by the National Center for Toxicology Research (NCTR)
Additional continuing education lecture series are planned to include speakers from the diagnostic and pharmaceutical industries responsible for the development of molecular diagnostics and of drugs for which pharmacogenomic data made a difference in therapeutic efficacy or safety.
Please contact us via email: fdagenomics@fda.hhs.gov for the presentations and more information on pharmacogenomics.
2009
- "Human Leukocyte antigens (HLAs) and adverse drug reactions (ADRs)" Shashi Amur, Ph.D, CDER April 2009, Walter Reed Army Institute of Research (WRAIR), MD presentations
2008
- "Pharmacogenomics Information in Drug Labels and Re-labeling efforts at FDA" Shashi Amur, Ph.D. and Padmaja Mummaneni, Ph.D., CDER, December 2008 Temple University, PA presentation
2007
- Genetic Testing to Help Reduce Chemotherapy Toxicity This June, 2007 FDA Patient Safety News video webcast discusses individualizing a drug's dose based on pharmacogenomic information.
2005
- Personalized Medicine: What Is It? How Will It Affect Health Care? [PDF], Felix W. Frueh, Ph.D., CDER, 11th Annual FDA Science Forum, April, 2005. This presentation provides a very basic understanding of genomics and pharmacogenomics.

