4.2 Prescription drugs: the Drug Approval Process

Reading

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 ”  NPR, FDA Green Lights Marijuana-Based Pharmaceutical Drug (an external site).

Listening

Please listen to the following Podcast:

• What A New CBD Drug Approval Might Mean For Medical Marijuana (an external site)  

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)

Watching

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

• The Shadow of Thalidomide (an external site)