关于FDA申报批批次与稳定性的指南.pdf

Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) June 2013 Generics Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 druginfo@ /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) June 2013 Generics TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND 1 III. DISCUSSION 2 1 Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alterna