Useful Regulatory Links

US Food & Drug Administration Centre for Drug Evaluation and Research
www.fda.gov/cder

European Medicines Agency
www.ema.europa.eu

ICH
www.ich.org

US Food & Drug Administration 'Critical Path' initiative
www.fda.gov/oc/initiatives/criticalpath

EU Innovative Medicines Initiative
http://imi.europa.eu/index_en.html

Pharmacometrics at FDA
http://www.fda.gov/cder/regulatory/pharmacometrics/default.htm