Painting a Better Picture of Quality

The FDA's approach to quality oversight has evolved in recent years, particularly with the establishment of the new Office of Pharmaceutical Quality (OPQ). OPQ exists within the Center for Drug Evaluations and Research (CDER) as a single unit dedicated to product quality with a simple mission: "to assure that quality medicines are available for the American public". In 2013, the FDA announced in the publication of the FDA Administration Safety and Innovation Act (FDASIA) that they intended to examine the use of selected quality metrics (the exact metrics will be decided upon and collected during an FDA quality metrics program) to support their risk-based inspection program. And more recently, the FDA published its draft guidance for industry related to the quality metrics request (1).