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.

Come January, if there is no quality target product profile (QTPP) in an abbreviated new drug application (ANDA), FDA might not file it, agency officials told a Generic Pharmaceutical Association workshop. Even though quality by design (QbD) remains optional for brand drugs, it will be expected for generics, said Office of Generic Drugs representatives who went on to outline pending question-based-review (QbR) revisions designed to elicit QbD information.