Guideline

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Q1A(R2)Stability Testing of New Drug Substances and Products
Short Title:	Q1A(R2)
Internet:	http://www.fda.gov/cder/guidance/5635fnl.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/cder/guidance/index.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