FDA Electronic Regulatory Submissions and Review
http://www.fda.gov/cder/regulatory/ersr/default.htm

Electronic Common Technical Document Specification (eCTD)
http://www.fda.gov/cder/regulatory/ersr/ectd.htm

FDA Electronic Submissions Gateway (ESG)
http://www.fda.gov/esg/default.htm

FDA Guidance Documents
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances

FDA Regulations – CFR Title 21
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

ICH
http://www.ich.org/cache/compo/276-254-1.html