FDA Guidance for Industry: Q1C Stability Testing for New Dosage Forms
Title:
FDA Guidance for Industry: Q1C Stability Testing for New Dosage Forms
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/ucm073374.pdf
Document Type:
FDA Guidance for Industry
Content:
This guideline defines the circumstances under which reduced stability data can be accepted, at the time of filing an application, in the case of new formulations of already approved medicines