Discovery and Development, Preclinical Research, Clinical Research, FDA Review, FDA Post-Market Safety Monitoring, are the steps involved in drug development. To stop or reverse the effects of disease drug development is done.
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.
Pharmaceutical regulatory authorities are responsible for overseeing and regulating therapeutics; including prescription and over-the-counter drugs, vaccines, cell therapies, and medical devices. They play a key role throughout the drug development process and are designed to ensure the safety, efficacy, accessibility and security of approved drugs. Throughout the development of the drug, the responsible pharmaceutical company will conduct pharmacovigilance activities.