The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072866.pdf