The Drug Development Process
Discovery and Development
Research for a new drug begins in the laboratory.
Research for a new drug begins in the laboratory.
Preclinical Research
Drugs undergo laboratory and animal testing to answer basic questions about safety.
Drugs undergo laboratory and animal testing to answer basic questions about safety.
Clinical Research
Drugs are tested on people to make sure they are safe and effective.
Drugs are tested on people to make sure they are safe and effective.
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.
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.
FDA Post-Market Safety Monitoring
FDA monitors all drug and device safety once products are available for use by the public.
FDA monitors all drug and device safety once products are available for use by the public.