美国FDA 指导原则 嗜酸性食管炎治疗药物开发行业指导 英文原版.pdfVIP

Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 2020 Clinical/Medical Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@ /drugs/guidance-compliance-regulatory-information/guidances-drugs U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 2020 Clinical/Medical Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND 1 III. DEVELOPMENT PROGRAM 3 A. Trial Population 3 B. Trial Design 4 C. Efficacy Considerations 4 1. Efficacy Assessments 4 2. Clinical Outcome Assessments 5 3. Statistical Considerations 6 D. Safety Considerations 7 IV. PEDIATRIC CONSIDERATIONS 8