This post was written by Paul Sheives. FDA seeks comments on the agency’s draft guidance document entitled ‘‘Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.’’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.