美国FDA 指导原则 普鲁士蓝药品--提交新药申请 英文原版.pdf

Guidance for Industry Prussian Blue Drug Products — Submitting a New Drug Application U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) January 2003 Clinical Medical Guidance for Industry Prussian Blue Drug Products — Submitting a New Drug Application Additional copies are available from: Division of Drug Information, HFD-240 Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 (Tel) 301-827-4573 /cder/guidance/index.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) January 2003 Clinical Medical TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND 1 III. NDAs SUBMITTED FOR PRUSSIAN BLUE DRUG PRODUCTS 2 A. Types of NDAs for Prussian Blue 2 1. Submitting 505(b)(2) Applications2 2. Submitting 505(b)(1) Applications 3 B. Content of NDAs for Prussian Blue3 1. Chemistry, Manufacturing, and Controls Information 3 2. Labeling for Prussian Blue 3 3. Patent Information 4 C. Exclusivity 4 1. Five-Year Marketing Exclusivity 5 2. Three-Year Exclusivity 5 3. Orphan Drug Exclusivity 6 4. Waiver of Exclusivity 6 D. Innovati