FDA Program Alignment Group
On September 6, 2013, Commissioner of Food and Drugs Margaret A. Hamburg, M.D., created the Program Alignment Group (PAG) comprised of senior FDA officials. The PAG was charged with identifying and developing plans to modify FDA’s functions, processes, and structure in order to meet the challenges posed by scientific innovation, globalization, the increasing breadth and complexity of the products that we regulate, and new legal authorities.
The PAG has worked together over several months to address the strategic, operational, and resource management alignment needed for FDA to continue to fulfill its public health mission and has provided recommendations to the Commissioner to improve communications and collaboration and clarify roles, responsibilities and decision rights.
The below memo provides an overview of her decisions , based on PAG recommendations, on a core set of operational changes, designated leads, and timeframes for developing more detailed implementation plans.