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Investigational New Drug Application

Meaning

An Investigational New Drug (IND) Application is a formal request submitted to a regulatory authority, such as the U.S. Food and Drug Administration (FDA), to obtain permission to begin human clinical trials for a new pharmaceutical agent. This application must provide comprehensive preclinical data on the drug’s composition, manufacturing, safety, and proposed clinical protocol. Securing an IND is a mandatory and critical step in the drug development pipeline, signifying the transition from laboratory research to human-focused investigation in clinical practice.