A decade after FDA’s Center for Drug Evaluation and Response launched its 21st Century Pharmaceutical Quality Initiative, the center and the pharmaceutical manufacturers it regulates have been reflecting on one of the initiative’s crowning achievements, the quality by design paradigm, and assessing where it stands and where it may be headed.
Slogging Toward Quality by Design
Ten years into FDA’s quality initiative, CDER Director Janet Woodcock acknowledges continued resistance to investing in QbD as a way of preventing quality problems in commercial manufacturing. Yet others in FDA and industry see adoption of the science- and risk-based approach spreading, even though manufacturers are often reluctant to disclose how much money it’s saving them.