FDA is Curious about Future Technologies
​[Posted on: Thursday, October 27, 2016]

Not many people know that FDA has an Emerging Sciences Working Group (ESWG) for the last year consisting of 15 leaders from various departments who brainstorm about innovative new technologies being developed but have not yet reached FDA review stage. All new innovations start as ideas which over time evolve through development and testing to product that may end up being regulated by FDA. By some estimates, innovative technologies could take 10 years or more before they become part of an IND or IDE. FDA wants to get a head-start on such technologies so presumably it can be prepared to regulate them by the time such technologies end up at FDA’s doors; and it may want to participate in the development of such technologies in various capacities. But as one can imagine, such information is not easy to find. Some technologies may be so new that not many people are currently working on them and very few publications are available on them. To be able to find such innovative ideas, FDA would like to reach out to other government agencies that fund research, evaluate patent submissions, and develop scientific policy to find out about innovations in the works. For that it has created a special “Emerging Science Idea Portal” where one can submit practically any innovative idea for FDA review. The purported mission of this venture is very broad and ambitious. But therein lies the caveat. There is no defined area of interest; rather the mandate is collect anything and everything. Since the innovations are expected to be very early in concept, it is not clear if they will ever see FDA’s formal review. Most scientists would love to have FDA opinions and review that early on but does FDA even have resources to act as mentors to such early ideas. What is the true value to this initiative? This is an excellent concept that seems utopian in its execution. Perhaps with time, FDA will develop better guidelines to interact with its ESWG.