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The FDA and the Regulation of Healthcare Interventions

This Spotlight Session on the FDA (US Food and Drug Administration), a supplemental video for the online course Understanding Evidence-Based Healthcare: A Foundation for Action, has been created by Consumers United for Evidence-based Healthcare (CUE). It is designed to help consumer advocates understand the history of drug regulation and the fundamentals of how drugs are approved in the US.

Course Objectives: Our goals in these videos 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.

Click here to watch on YouTube


This course 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


  • Kay Dickersin – Project concept, initial module framework, content oversight, feedback and revision
  • Musa Mayer – Primary developer of individual modules and script, lecturer
  • Kristina Lindsley – Project coordination, preparation of presentation and evaluation materials
Developers: Kay Dickersin, Musa Mayer