Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers . Guidance for Industry was updated in October 2017 from the June 2016 edition. This guidance provides information about the implementation of FDA’s regulations on expanded access to investigational drugs under an investigational new drug application (IND). Expanded access refers to the use of an investigational drug when the primary purpose is to diagnose, monitor, or treat a patient’s condition rather than to obtain the kind of information about the drug that is derived from clinical trials.  (fda.gov)