Will the FDA have the leadership it needs in 2019? Perhaps not. The long-awaited reorganization of the U.S. FDA’s Office of New Drugs (OND) is close to fruition. Ideally, the addition of several new review divisions means the agency will be better able to distribute its everincreasing review workload. However, recent high-level departures call into question whether the agency can staff these new divisions. The FDA may need to turn to younger, less experienced leaders. Learn what a restructured FDA will look like, and explore what staffing decisions could mean for the agency and a rapidly changing industry.