Greenwich Biosciences worked with the FDA for years to bring the first prescription cannabidiol (CBD) medicine to US patients in 2018.
Take a closer look at the FDA approval process.
- Led by the treatment manufacturer, discovery and development begins
- New compounds are identified
- Preliminary preclinical research is initiated
- The treatment manufacturer begins lab studies and animal testing
- Basic safety is evaluated
- Human studies begin to be planned
- Investigational New Drug applications are submitted to the FDA based on preclinical study results
- The treatment manufacturer oversees human trials that test for safety, efficacy, and dosing in 100s to 1000s of patients
- Inspections are conducted by the FDA to confirm a company’s clinical and manufacturing processes meet FDA standards
- The data from the trials are summarized and submitted as a New Drug Application (NDA) to the FDA
- The FDA thoroughly examines all of the submitted data in the NDA to decide whether a treatment should be approved
- Once approved and available, the FDA continues to monitor the manufacturing and adverse events of a medication, as well as any communication to the public
- Additional studies may be conducted to provide more information