Đang chuẩn bị liên kết để tải về tài liệu:
Guidance for Industry Botanical Drug Products

Experts agree that attempts to prevent childhood obesity and its health consequences, such as type 2 diabetes, must shift the focus from treating overweight children to addressing health disparities among children of varying socio-economic status. and mitigating the social and environmental factors that contribute to the declining health of children overall. The nation’s health care costs for treating diabetes are $92 billion. Failed efforts to treat childhood obesity through weight reduction and reliance on pharmaceutical or surgical strategies are not only costly, they also. | Guidance for Industry Botanical Drug Products U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER June 2004 Chemistry Guidance for Industry Botanical Drug Products Copies of this Guidance are available from Division of Drug Information HFD-240 Office of Training and Communications Center for Drug Evaluation and Research CDER Food and Drug Administration 5600 Fishers Lane Rockville MD 20857 Tel 301-827-4573 Internet at http www.fda.gov cder guidance index.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER June 2004 Chemistry TABLE OF CONTENTS I. INTRODUCTION.1 II. BACKGROUND.2 III. GENERAL REGULATORY APPROACHES.3 A. Marketing Under OTC Drug Monograph Versus Approved NDA.4 B. CMC Information for Botanical Drug Products.5 C. CMC and Toxicology Information to Support Initial Studies.5 D. Applicability of Combination Drug Regulations.6 IV. MARKETING A BOTANICAL DRUG UNDER AN OTC DRUG MONOGRAPH.6 V. MARKETING A BOTANICAL DRUG UNDER AN NDA.7 VI. INDS FOR BOTANICAL DRUGS.7 A. IND Information for Different Categories of Botanicals.7 B. Basic Format for INDs.9 1. Cover Sheet see 312.23 a 1 .9 2. Table of Contents see 312.23 a 2 .9 3. Introductory Statement and General Investigational Plan see 312.23 a 3 .9 4. Investigator s Brochure see 312.23 a 5 .9 5. Protocols 312.23 a 6 .9 6. Chemistry Manufacturing and Controls 312.23 a 7 .10 7. Pharmacological and Toxicological Information 312.23 a 8 .13 8. Previous Human Experience With the Product 312.23 a 9 .13 VII. INDS FOR PHASE 1 AND PHASE 2 CLINICAL STUDIES OF LAWFULLY MARKETED BOTANICAL PRODUCTS WITHOUT SAFETY CONCERNS.13 A. Description of Product and Documentation of Human Use.13 1. Description of Botanicals Used 312.23 a 3 i .14 2. History of Use 312.23 a 3 ii a 9 .14 3. Current Marketed Use 312.23 a 3 ii a 9 .14 B. Chemistry Manufacturing and Controls . 14 1. Botanical Raw Material 312.23