The Food and Drug Administration is the regulatory body that has the most direct and daily impact on average American consumers, whether they know it or not. It has a complex mission of ensuring that the products under its purview are safe and effective, while at the same time advancing innovation that will benefit the American people. How have the FDA's responsibilities and challenges changed over time? What is the state of the agency's capacity and resources today? Where do the greatest opportunities to benefit patients in the future lie? And what role does the public have in the process?