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IND Application

Meaning

An Investigational New Drug (IND) Application is a comprehensive regulatory submission filed by a sponsor, typically a pharmaceutical company or researcher, with the relevant national health authority, such as the U.S. Food and Drug Administration (FDA), before commencing human clinical trials. This application is a request for permission to administer an unapproved drug or biologic to human subjects and must provide detailed information on the drug’s composition, manufacturing process, and quality control. Furthermore, the IND must include all available preclinical data from animal studies regarding pharmacology and toxicology, along with the proposed clinical trial protocols and investigator qualifications. It is the essential first step in the formal drug development process.