Regulatory Responsibilities of the Bureau of Medical Devices. Module I: The Food, Drug, and Cosmetic Act (Part 1). Leader Guide and Student Workbook

摘要

This leader guide contains the following five components: (1) Leader Introduction, (2) Session Plan, (3) Student Workbook, (4) Pretest and Post-Test, and (5) Videotape Script. The Leader Introduction covers general planning and teaching techniques for a small or large group setting. The Session Plan provides the instructor with specific information on planning and leading a training session covering the information contained in Module I's Student Workbook. The Student Workbook contains historical background infomation including landmark cases, and decisions related to the Federal Food, Drug, and Cosmetic Act. The main purpose of the Act, its overall purview, and authorities are also presented. A definition, example of the product, and historical background infomation are included for each product area (foods, drugs, medical devices, cosmetics, animal drugs and feeds). Such terms as interstate commerce, adulteration, and misbranding are specifically described.