FDA QUALITY-BY-DESIGN PILOT PROGRAMS

...for new and generic drugs are demonstrating the progress and the remaining challenges in building a stronger QbD foundation for the CMC review process. With one application cleared and several more under review in the NDA pilot, experience is now growing on how to shape a QbD-based filing from which more regulatory flexibility can flow. How detailed the QbD information should be and how to design a regulatory agreement that will clarify the ongoing commitments are among the issues generating discussion as the NDA pilot proceeds. The Office of Generic Drugs is also digesting the initial positive experience with its question-based review initiative integrating QbD principles into the ANDA review process. [An update on the NDA CMC pilot program by Office of New Drug Quality Assessment official Chi-wan Chen at the DIA annual meeting in late June and summaries by industry participants of their firms’ experience with the NDA and ANDA initiatives are included.]