Providing an investigational drug outside of a controlled trial carries inherent development risks, but it can also be a win-win proposition for patients and sponsors when managed well, veterans of "expanded access" programs say. According to the FDA's broad definition, "expanded access" could mean a one-time supply of a drug to a particular patient, or a program that serves tens of thousands of patients. Globally, the terms "early access" and "compassionate use" are also used for similar programs.Demand...