gov/Drugs/GuidanceComplianceRegulatotylnfortnation/Guidanceildefault.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2016 Clinical/Medical EFTA_R1_00015157 EFTA01734943 TABLE OF CONTENTS I. INTRODUCTION II. BACKGROUND 2 III. DEVELOPMENT PROGRAM