Federal Register Notice: FDA is making available a draft guidance, Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND. It is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an investigational new drug application (IND). It describes the basic criteria for when an IND is required and specific situations in which an IND is not required. It also discusses a range of issues that, according to the agency, have been the source of confusion or misperceptions about the application of the IND requirements. To download this guidance, click here. To view this notice, click here.