The aim of this workshop is to educate clinical researchers on the regulatory requirements for clinical studies of investigational drugs that require an Investigational New Drug (IND) application, and to help the audience understand when those regulations apply. The workshop will cover FDA meetings, IND content, IND submission and review, IND maintenance, and the use of expanded access INDs. The goal of this workshop is to support a better understanding of FDA regulations that will lead to better compliance with those regulations.