Sponsor-Investigator [Food and Drugs] Law and Legal Definition

Pursuant to 21 CFR 312.3 [Title 21 Food and Drugs; Chapter I Food and Drug Administration, Department of Health and Human Services; Subchapter D Drugs for Human Use; Part 312 Investigational New Drug Application; Subpart A General Provisions], Sponsor-Investigator means “an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.”