Conclusion
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.
Acknowledgments
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, david.skanchy@fda.hhs.gov
References
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See the related generic-drug story by FDA and generic-drug industry representatives.
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