This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. Whom Do You Contact for More Information?.What Statutory Definitions Might Apply?.What FDA Authority Might Apply to CAM Products?.How Do CAM Domains Relate to Products That We Regulate?.What Are "Manipulative and Body-Based Practices?".What Are "Biologically Based Practices?".What Is Complementary and Alternative Medicine (CAM)?.Department of Health and Human ServicesĬenter for Biologics Evaluation and Research (CBER)Ĭenter for Drug Evaluation and Research (CDER)Ĭenter for Devices and Radiological Health (CDRH)Ĭenter for Food Safety and Applied Nutrition (CFSAN) Office of Communication, Training, and Manufacturers Assistance (HFM-40) All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.įor questions regarding this draft document, contact (CBER) Sheryl Lard-Whiteford at 30, (CDER) Daniel Nguyen at 30, (CDRH) Ted Stevens at 30, or (CFSAN) Wayne Amchin at 30. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. This guidance document is being distributed for comment purposes only.Ĭomments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Center for Biologics Evaluation and Research
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