In October, FDA issued a draft guidance entitled "Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can be Conducted Without an IND." FDA explains that the draft guidance is intended to describe the basic criteria for when an IND is required, specific situations in which an IND is not required, and a range of issues that have been the source of confusion or misperceptions within the academic research community and the pharmaceutical industry about the application of the IND regulations. The guidance addresses, for example, what is a "clinical investigation," research involving lawfully marketed drugs, the extent to which a study could involve modifications to the marketed drug and still be exempt from the IND regulations, bioavailability and bioequivalence studies, studies to support labeling changes and studies involving only healthy volunteers. The guidance also reminds industry that there is a FDA process for addressing inquiries concerning the applicability of the IND requirements.