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U.S. Department of Health and Human Services

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Percentage of New Drug Applications (NDAs) containing Quality by Design (QbD) elements (New Molecular Entity (NME) and non-NME). Cumulative total reported each Fiscal Year.

Annual Target: 10%

Dictionary: Quality by Design (QbD): A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management (ICH Q8R2). The implementation of QbD will enhance the assurance of pharmaceutical quality in the U.S. market, improve the quality of Chemistry, manufacturing, and controls information submitted in Investigational New Drug (IND), NDA, NDA supplement, and Drug Master File (DMF) submissions, and improve the ONDQA regulatory review processes.


These measures have been retired as CDER has created new measures for FY13 which align to their four functional areas of 1) Regulatory Review and Drug Safety, 2) Drug Quality and Compliance, 3) Transparency and Public Outreach, and 4) Regulatory Science Research.

Fiscal Year - 2010

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Annual Target: 10%

TimeTargetPercent
Oct 2009N/A0
Nov 2009N/A7
Dec 2009N/A8
Jan 2010N/A7
Feb 2010N/A9
Mar 2010N/A8
Apr 2010N/A8
May 2010N/A7
Jun 2010N/A7
Jul 2010N/A8
Aug 2010N/A8
Sep 2010N/A8

Number of NDAs containing QbD elements received. Cumulative total reported each Fiscal Year.

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A0
Nov 2009N/A1
Dec 2009N/A3
Jan 2010N/A3
Feb 2010N/A4
Mar 2010N/A5
Apr 2010N/A6
May 2010N/A6
Jun 2010N/A6
Jul 2010N/A8
Aug 2010N/A8
Sep 2010N/A9

Number of NDAs received. Cumulative total reported each Fiscal Year.

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A8
Nov 2009N/A15
Dec 2009N/A38
Jan 2010N/A44
Feb 2010N/A47
Mar 2010N/A63
Apr 2010N/A74
May 2010N/A84
Jun 2010N/A89
Jul 2010N/A99
Aug 2010N/A103
Sep 2010N/A111

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.