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The pharmaceutical industry’s grand challenge”

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 pre-clinical 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.

New chemical entity development[edit]

Broadly, the process of drug development can be divided into pre-clinical and clinical work.

Timeline showing the various drug approval tracks and research phases[citation needed]