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U.S. Department of Health and Human Services

About FDA

Percentage of New Drug Applications (NDAs) for new molecular entities (NMEs) containing Quality by Design (QbD) elements. Cumulative total reported for the Fiscal Year.

Annual Target: 20%

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: 20%

TimeTargetPercent
Oct 2009N/A0
Nov 2009N/A20
Dec 2009N/A10
Jan 2010N/A10
Feb 2010N/A18
Mar 2010N/A13
Apr 2010N/A17
May 2010N/A16
Jun 2010N/A15
Jul 2010N/A21
Aug 2010N/A21
Sep 2010N/A21

Number of NDAs for NMEs containing QbD elements received. Cumulative total reported for the Fiscal Year.

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A0
Nov 2009N/A1
Dec 2009N/A1
Jan 2010N/A1
Feb 2010N/A2
Mar 2010N/A2
Apr 2010N/A3
May 2010N/A3
Jun 2010N/A3
Jul 2010N/A5
Aug 2010N/A5
Sep 2010N/A5

Number of NDAs for NMEs received in the month. Cumulative total reported for the Fiscal Year

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A3
Nov 2009N/A5
Dec 2009N/A10
Jan 2010N/A10
Feb 2010N/A11
Mar 2010N/A15
Apr 2010N/A18
May 2010N/A19
Jun 2010N/A20
Jul 2010N/A24
Aug 2010N/A24
Sep 2010N/A24

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.