U.S. flag An official website of the United States government
  1. Home
  2. For Patients
  3. Learn About Drug and Device Approvals
  4. The Drug Development Process
  1. Learn About Drug and Device Approvals

The Drug Development Process

 
Discovery and Development
Research for a new drug begins in the laboratory.
More Information
 
Preclinical Research
Drugs undergo laboratory and animal testing to answer basic questions about safety.
More Information
 
Clinical Research
Drugs are tested on people to make sure they are safe and effective.
More Information
 
FDA Review
FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it.
More Information
 
FDA Post-Market Safety Monitoring
FDA monitors all drug and device safety once products are available for use by the public.
More Information
 


Back to Top