UCM414598 ANDA Submissions – Refuse to Receive for Lack of Justification of Impurity Limits.pdf

ANDA Submissions – Refuse to Receive for Lack of Justification of Impurity Limits Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2016 Generics ANDA Submissions – Refuse to Receive for Lack of Justification of Impurity Limits Guidance for Industry Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 220 1 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, MD 20993-0002 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) August 2016 Generics Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND 2 III. JUSTIFYING IMPURITY LIMITS IN DRUG SUBSTANCES AND PRODUCTS . 3 A. Refusal to Receive for Lack of Impurities Information 3 B. Providing Justification for Impurity Limits 4 Contains Nonbinding Recommendations ANDA Submissions – Refuse to Receive for Lack of Justification of Impur