Since the launch of the Office of New Drug Quality Assessment (ONDQA) CMC pilot program in July 2005, over 40 Quality by Design (QbD) containing applications have been submitted, reviewed, and approved by ONDQA, both within and outside of the pilot. Although challenges still remain, many approaches for preparation and review of QbD containing applications have been established and efforts are underway toward international harmonization. This presentation will discuss the progress made to date in QbD and remaining scientific and regulatory challenges. Additionally, an overview will be given of harmonization efforts, including the recently announced pilot between FDA and the European Medicines Agency (EMA) for QbD containing applications.
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