The FDA and the Regulation of Healthcare Interventions-A Spotlight Session

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This Spotlight Session on the FDA (US Food and Drug Administration), a supplemental module for the online course Understanding Evidence-Based Healthcare: A Foundation for Action, has been created by the United States Cochrane Center as part of a project undertaken by Consumers United for Evidence-based Healthcare (CUE). It is designed to help users understand the history of drug regulation and the fundamentals of how drugs are approved in the US.  We recommend that you register for this Spotlight Session after completing  the course, Understanding Evidence-based Healthcare:  A Foundation for Action.

This Spotlight Session was funded in part by:

  • A conference grant (#R13 HS13368) from The Agency for Healthcare Research and Quality (K. Dickersin, Principal Investigator)
  • Johns Hopkins Bloomberg School of Public Health

Session Developers:Course Developers - Dickersin,Mayer 

  • Musa Mayer, MS, MFA
    AdvancedBC.org
    Consumer Advocate
    Primary developer of individual modules and script, lecturer
  • Kay Dickersin, MA, PhD
    US Cochrane Center,
    Johns Hopkins Bloomberg School of Public Health
    Project concept, initial module framework, content oversight, feedback and revision
  • Kristina Lindsley, MS, Project coordination, preparation of presentation and evaluation materials
Session Objectives:
Our goals in this Spotlight Session are to:
  • Provide a brief history of drug development regulation in the US,
  • Define the roles, scopes, and functions of the FDA, and
  • Illustrate the FDA approval process using a real-life example.

Session Description:

 In these four parts, we will illustrate key concepts with compelling real-world examples, covering the following topics and issues. Run times do not take into account interruptions or a second review of selected slides.

  • Part A: A Brief History of Drug Development Regulation in the US (27 minutes)
  • Part B: FDA’s Role, Scope, and Function (20 minutes)
  • Part C: Avastin (Bevacizumab) A Question of Efficacy and Safety (24 minutes)
  • Part D: Summary and Conclusion (6 minutes)