Drug Development Process

The U.S. Food and Drug Administration (FDA) is responsible for for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation. Drug development involves 5 major steps. Discovery/Concept, Preclinical Research, Clinical Research, FDA Review and FDA Post Market Safety Monitoring. Learn more about the drug development process here.