In the United States, all new drugs and/or medical devices are subject to various levels of scrutiny by FDA.  The Food, Drug, and Cosmetic act of 1938 set into play the requirement for new drugs to be determined safe before they can be marketed.  Sometimes the regulatory process can be time consuming, but the whole reason regulations exist is for the protection of the U.S. population at large.    History is full of examples of treatments with good intentions causing more harm than good.  Think of it as a necessary evil if you will. What is the perfect balance between fastest path to market and proper safety evaluation?