Where can I find information about in vitro diagnostic tests used in pharmacogenomics?
FDA has a number of initiatives related to pharmacogenomics, including the co-development of pharmacogenomic-based drugs and in vitro diagnostic tests. The Office of Combination Products participated in a public meeting held on July 29, 2004 (http://www.diahome.org/Content/Events/04040.pdf ). FDA is currently developing a guidance document with recommendations for the co-development of pharmacogenomic-based drugs and in vitro diagnostic tests. FDA and industry co-sponsored two earlier workshops in May 2002 and November 2003, and CDER published a draft guidance document for pharmacogenomic data submissions in November 2003 ( http://www.fda.gov/cder/guidance/5900dft.pdf ). CDRH published draft guidance on Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns in February 2003 (http://www.fda.gov/cdrh/oivd/guidance/1210.html). Additional information on previous FDA-industry workshops on pharmacogenomics is available in the following publications: Pharmacogenomics 200
