FDA Guidance for Industry: Q1A(R2)Stability Testing of New Drug Substances and Products
Title:
FDA Guidance for Industry: Q1A(R2)Stability Testing of New Drug Substances and Products
Short Title:
Q1A(R2)
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 ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073369.pdf
Document Type:
FDA Guidance for Industry
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.