Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational New Drug Applications-Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance for clinical investigators, sponsors, and institutional review boards (IRBs) entitled "Investigational New Drug Applications (INDs)--Determining Whether Human Research Studies Can Be Conducted Without an IND." The guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and IRBs in determining whether human research studies must be conducted under an IND. The guidance describes the basic criteria for determining when an IND is required, describes specific situations in which an IND is not required, and addresses a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND regulations.