http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
eCTD specification : questions & answers and change requests
Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
International Conference on Harmonisation.
Title from PDF title page (viewed on July 2, 2009).
Mode of access: Internet at the FDA web site. Address as of 7/2/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129614.pdf ; current access is available via PURL.