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
- Musa Mayer, MS, MFA
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
- 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.
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)