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.

In 2014, 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 program established detailed action plans for FY 2015 and FY 2016. These action plans focus on what will be accomplished during each fiscal year, 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.

Fiscal Year 2016 Program Alignment Action Plans

• FDA Program Alignment Biological Products FY 2016 Action Plan
• FDA Program Alignment Bioresearch Monitoring Program FY 2016 Action Plan
• FDA Program Alignment Human and Animal Food Program FY 2016 Action Plan
• FDA Program Alignment Medical Devices and Radiological Health FY 2016 Action Plan
• FDA Program Alignment Pharmaceutical Quality FY 2016 Action Plan
• FDA Program Alignment Tobacco FY 2016 Action Plan

More Information

• Program Alignment and the Office of Regulatory Affairs
• Program Alignment Group Recommendations - Decision
• 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