美国FDA 指导原则 严重细菌性疾病治疗中未满足医疗需求的患者的抗菌治疗 英文原版.pdfVIP

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2017 Clinical/Antimicrobial Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2017 Clinical/Antimicrobial TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND 2 III. QUESTIONS AND ANSWERS 3 BIBLIOGRAPHY 16 Contains Nonbinding Recommendations Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases 1 Gu