FDA seeks comments on the agency’s draft guidance document entitled ‘‘Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.’’ The document is intended: to (1) describe when an IND is required; (2) describe specific situations in which an IND is not required; and (3) clarify certain related issues. Issues addressed in the guidance include the definition of a “lawfully marketed drug,” research for noncommercial purposes, endogenous compounds, live organisms, and dietary supplements. The document also contains a section providing answers to frequently-asked questions. FDA is accepting written comments until January 12, 2011.