Regulatory Responsibilities of the Bureau of Medical Devices. Module II: The Food, Drug, and Cosmetic Act (Part 2). 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 II's Student Workbook. The Student Workbook is a continuation of Module I, on the Federal Food, Drug, and Cosmetic Act. This module offers a more in-depth review of some of the authorities described by the Act. The authorities for the regulation of individual products are described, including the provisions for foods, drugs, medical devices, cosmetics, and animal drugs and feeds. The scope of regulatory authorities and general administrative provisions are reviewed.