FDA Presses Generics Firms to Speed Adoption of QbD, While Questions on Use of Prior Knowledge Persist
This article was originally published in The Gold Sheet
Executive SummaryFDA officials are telling generic drug makers that the agency will be looking for their abbreviated new drug applications to include the type of pharmaceutical development studies and risk assessments that are spelled out in recent guidelines from the International Conference on Harmonization.
You may also be interested in...
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.