The "FDA Effect": Tough Going for Big Medical Innovation?

The Food and Drug Administration is tasked with protecting the public health by assuring the safety and effectiveness of drugs, biological products, and medical devices.  Nevertheless, FDA is too often associated with restricted and delayed access to much needed medical therapies, as well as allegations of innovation being driven outside the United States; all consequences of regulation that appear contrary to the Agency’s core mission.  This presentation offers insight into factors that influence FDA decision-making and behavior including the culture of the organization, the regulatory pendulum that swings with changes in leadership, and key aspects of the law and administrative procedures. Attendees will develop an appreciation for the challenges and impediments that interfere with FDA achieving the optimum regulatory balance.