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Draft Guidance for Industry: Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug AdministPage 1Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration DRAFT GUIDANCEThis guidance document is being distributed for comment purposes only.Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA305) Food and Drug Administration 5630 Fishers Lane rm. 1061 Rockville MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register. For questions regarding this draft document contact (CBER) Sheryl LardWhiteford at 3018270379 (CDER) Daniel Nguyen at 3018278971 (CDRH) Ted Stevens at 3015941184 or (CFSAN) Wayne Amchin at 3018276739. U.S. Department of Health and Human Services Food and Drug Administration December 2006 Page 2Guidance for Industry: Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug AdministrationAdditional copies are available from: Office of Communication Training and Manufacturers Assistance (HFM40)Center for Biologics Evaluation and Research Food and Drug Administration 1401 Rockville Pike Suite 200N Rockville MD 208521448 Phone: 8008354709 or 3018271800 Internet: http://www.fda.gov/cber/guidelines.htmU.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) Center for Devices and Radiological Health (CDRH) Center for Food Safety and Applied Nutrition (CFSAN) December 2006 2Page 3Table of Contents I. Why Are We Issuing This Guidance?.. 1 II. What Is Complementary and Alternative Medicine (CAM)?.. 2 A. What Are Biol ...

Source: www.fda.gov

 

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