FDA Patient Engagement Initiatives

Section 1137 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directs the FDA to develop and implement strategies to solicit the views of patients during the development process of medical products (drugs, devices, biologics) and consider the perspectives of patients during regulatory discussions. The statute recognizes the value of patient input by facilitating increased involvement of patients earlier in the regulatory process of medical product review. 

FDA has developed and continues to develop programs and initiatives for patients and families to have a variety of opportunities to provide input into FDA decision-making. This session will provide highlights of FDA key programs and initiatives related to patient engagement.