Guidance Documents
US FDA Centre for Drug Evaluation and Research (CDER) Guidance Documents
http://www.fda.gov
International Conference on Harmonisation (ICH) guidelines available at the ICH website.
http://www.ich.org
Guidelines at the 'Step 4' level are available from the website of the
European Agency for the Evaluation of Medicinal Products (EMEA).
http://www.ema.europa.eu/
The guidelines are subsequently published by the
European Commission in Volume III of the Rules Governing Medical Products in the European Union.
http://ec.europa.eu