TAILIEUCHUNG - 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 . 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 cder guidance . Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER June 2004 Chemistry TABLE OF CONTENTS I. II. III. GENERAL REGULATORY A. Marketing Under OTC Drug Monograph Versus Approved B. CMC Information for Botanical Drug C. CMC and Toxicology Information to Support Initial D. Applicability of Combination Drug IV. MARKETING A BOTANICAL DRUG UNDER AN OTC DRUG V. MARKETING A BOTANICAL DRUG UNDER AN VI. INDS FOR BOTANICAL A. IND Information for Different Categories of B. Basic Format for 1. Cover Sheet see a 1 .9 2. Table of Contents see a 2 .9 3. Introductory Statement and General Investigational Plan see a 3 .9 4. Investigator s Brochure see a 5 .9 5. Protocols a 6 .9 6. Chemistry Manufacturing and Controls a 7 .10 7. Pharmacological and Toxicological Information a 8 .13 8. Previous Human Experience With the Product a 9 .13 VII. INDS FOR PHASE 1 AND PHASE 2 CLINICAL STUDIES OF LAWFULLY MARKETED BOTANICAL PRODUCTS WITHOUT SAFETY A. Description of Product and Documentation of Human 1. Description of Botanicals Used a 3 i .14 2. History of Use a 3 ii a 9 .14 3. Current Marketed Use a 3 ii a 9 .14 B. Chemistry Manufacturing and Controls . 14 1. Botanical Raw Material

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