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Investigator-Initiated Draft Guidance from FDA

This website provides an in progress draft guidance developed by the FDA to help researchers understand their responsibilities as sponsor-investigator when they initiate and lead an investigational drug trial. A sponsor-investigator is defined by the FDA as "an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed".

Creator Organization	University of Virginia
Categories	PROPOSE > SPECIAL TOPICS > Multi-Center Studies
Website	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigational-new-drug-applications-prepared-and-submitted-sponsor-investigators

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