Department of Health and Human Services

Patient Network

Bringing Your Voice to Drug and Device Approval and Safety

The Drug Development Process


Discovery and Development

Research for a new drug begins in the laboratory.


Preclinical Research

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.


FDA Review

FDA review teams thoroughly examine all of the submitted data related to the drug and make a decision to approve or not to approve it.


FDA Post-Market Safety Monitoring

FDA monitors all drug safety once products are available for use by the public.