(299a) Question-Based Review for Generic Drugs

The Food and Drug Administration Office of Generic Drugs (OGD) has developed and implemented Question-based Review (QbR) with the broad goal of encouraging generic applicants to include quality-by design (QbD) principles in their product and process development. In light of this goal, OGD outlined the following four major benefits: ? Ensure product quality through product design and performance-based specifications ? Facilitate continuous improvement and reduce CMC supplements through risk assessment ? Enhance the quality, transparency, and consistency of reviews through standardized review questions ? Reduce CMC review time when applicants submit a quality overall summary that adequately addresses the QbR questions.

This presentation will provide an assessment of how QbR has contributed to achieving these benefits. It will identify the current approach's strengths and areas for improvement.