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FDA Guidance for Industry: Q1C Stability Testing for New Dosage Forms


Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; ;

Document Type:
FDA Guidance for Industry
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

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