4.2 Prescription drugs: the Drug Approval Process


Review the information on The Drug Development Process (an external site) that covers how drugs are developed in a five-step process:

  • Step 1: Discovery and Development
  • Step 2: Preclinical Research
  • Step 3: Clinical Research
  • Step 4: FDA Drug Review
  • Step 5: FDA Post-Market Drug Safety Monitoring

Next review Dr. Ashutosh Tiwari’s slide deck on Clinical Trial Phases (an external site). Take a close look at slide #8 which offers an overview of the drug approval process with Phases and timelines.

And finally, read the following NPR article “FDA Green-Lights Marijuana-Based Pharmaceutical Drug ”  https://www.npr.org/sections/health-shots/2018/06/25/623236189/fda-green-lights-marijuana-based-pharmaceutical-drug (an external site).


Please listen to the following Podcast:

Optional Listening: check out the Freakonomics podcast’s coverage on Drug Trials


Please watch the following video to learn more about complications with clinical trials:


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Drugs, Health & Behavior by Jacqueline Schwab and Denise Salters is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License, except where otherwise noted.

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