FDA Program Alignment
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.
Over the last year, officials were tasked with developing action plans to modify FDA’s functions and processes in order to address these challenges. The Directorates, Centers and the Office of Regulatory Affairs (ORA) collaborated closely to define the changes needed to be made in order to align ourselves more strategically and operationally and meet the greater demands placed on the agency. As a result, each regulatory program has established detailed action plans . These action plans focus on what will be accomplished in FY 2015, and outline the need to develop detailed future plans, for the next five years in some cases. The plans represent what each Center and the Office of Regulatory Affairs have agreed are the critical actions to jointly fulfill FDA’s mission in the key areas of specialization; training; work planning; compliance policy and enforcement strategy; imports; laboratory optimization; and information technology.
Program Alignment Action Plans
Biological Products FY2015 Program Alignment Action Plan Bioresearch Monitoring Program FY2015 Program Alignment Specialization Action Plan Food and Feed Program FY2015 Program Alignment Action Plan Pharmaceuticals FY 2015 Program Alignment Action Plan Tobacco FY2015 Program Alignment Action Plan Medical Devices and Radiological Health FY2015 Program Alignment Action Plan