Question-Based Review: An FDA Reviewer's Perspective - Pharmaceutical Technology

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Question-Based Review: An FDA Reviewer's Perspective
The author analyzes, from an agency perspective, whether question-based review has improved product quality or made the review process easier for regulators or for industry.

Pharmaceutical Technology
Volume 33, Issue 10


Based on the original vision of QbR, FDA and sponsors have made significant progress. Gains in review quality, consistency, and efficiency have been realized as a result, but progress can still be made in several areas. Some important elements originally identified as critical at the outset of QbR have not yet been addressed. OGD can improve the QbR process by using increases in product and process knowledge to enhance efficiency by implementing a supplement-reduction strategy described in the original QbR vision and by developing an abbreviated review format for low-risk products. Sponsors should continue to improve the content and quality of their responses to the QbR questions and of the supporting information in the PDRs. This strategy will facilitate gains in review efficiency for OGD and aid sponsors as the transition to a formal QbD approach takes shape in the future.


The author wishes to thank Lawrence Yu, PhD, director for science, and Andre Raw, PhD, a senior chemist, both at FDA's Office of Generic Drugs, for their valuable insights.

David J. Skanchy, PhD, is a review chemist with the US Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, tel. 240.276.8552, fax 240.276.8582,


1. L.X. Yu et al., "US FDA Question-Based Review for Generic Drugs: A New Pharmaceutical Quality Assessment System," J. Generic Med. 4 (4), 239–248 (2007).

2. FDA, "White Paper: Question Based Review (QbR) for Generic Drugs: An Enhanced Pharmaceutical Quality Assessment System" (FDA, Rockville, MD, Apr. 2009).

3. A. Srinivasan and R. Iser, "FDA Office of Generic Drugs Question-Based Review Initiative: An Update—Past, Present, and Next Steps," J. Valid. Technol. 15 (2), 10–12 (2009).

4. L.X. Yu, "Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control," Pharm. Res. 25 (4), 781–791 (2008).

5. R. Lionberger et al., "Quality by Design: Concepts for ANDAs," AAPSJ. 10 (2), 268–276 (2008).

6. L.X. Yu et al., "FDA Office of Generic Drugs' Pharmaceutical Quality Initiative: Progress and Feedback on Question-Based Review," Pharm. Eng. 27 (6), 52–61 (2007).

7. FDA, "Example Quality Overall Summary ER Product," (FDA, Rockville, MD).

8. FDA, "Example Quality Overall Summary IR Product," (FDA, Rockville, MD).

9. FDA, "QbR Frequently Asked Questions," (FDA, Rockville, MD, June 2007).

See the related generic-drug story by FDA and generic-drug industry representatives.


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