FDA announced Sept. 6 that it has formed a Program Alignment Group “to identify and develop plans to modify agency functions and processes in order to best achieve mission-critical agency-objectives,” FDA Commissioner Margaret Hamburg wrote in a memo to FDA staff. The group will consist of the acting deputy commissioner for global regulatory operations and policy, the deputy commissioner for foods and veterinary medicine, the associate commissioner for regulatory affairs and acting deputy, and each of the medical product center directors.
“We need to transition to distinct commodity-based and vertically-integrated regulatory programs with well-defined leads, coherent policy and strategy development, well-designed...