Guideline

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.

Q1A(R2)Stability Testing of New Drug Substances and Products
Short Title:	Q1A(R2)
Internet:	http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073369.pdf
Origin/Publisher:	Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Content:	This revised ICH guidelines regulate the scope necessary for marketing authorization of the stability testing of new active substances and finished medicinal products containing new active substances.
Document Type:	FDA Guidance for Industry