Section IV of this guidance address

Section IV of this guidance addresses clinical investigations that are exempt from the IND requirements. As the guidance states, the potential sponsor or sponsor-investigator of a planned clinical investigation using a marketed drug is responsible for determining whether the investigation meets the criteria for an exemption. If there is any uncertainty about whether the exemption criteria are met,the potential sponsor or sponsor-investigator can seek advice from FDA on the applicability of the IND regulations (refer to section VIII of the guidance for information on how to contact FDA).