FDA regulatory efforts in a changing environment

In the face of the Food and Drug Administration's (FDA's) Pharmaceutical CGMPs for the 2 Is' Century Initiative (the Initiative), the FDA finds itself in the position of re-establishing its own "design space". The Agency efforts include adopting a Quality Management S stems (QMS) approach for the development of pharmaceuticals with emphasis on manufacturing process control strategies and risk activities to better manage the lifecycle, of a drug product. The Office of Pharmaceutical Science (OPS) is exploring ways to apply the standard QMS approach to the chemistry manufacturing, and controls assessment process and policy development efforts.