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
- Bad Medicine, Part 1: (Drug) Trials and Tribulations (an external site)
- Bad Medicine, Part 2: (Drug) Trials and Tribulations (an external site)
Please watch the following video to learn more about complications with clinical trials:
- The Shadow of Thalidomide (an external site)