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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 - 2011

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Annual Target: 20%

TimeTargetPercent
Oct 2010N/A0
Nov 2010N/A33
Dec 2010N/A25
Jan 2011N/A25
Feb 2011N/A21
Mar 2011N/A27
Apr 2011N/A22
May 2011N/A20
Jun 2011N/A17
Jul 2011N/A17
Aug 2011N/A15
Sep 2011N/A13

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A1
Dec 2010N/A2
Jan 2011N/A3
Feb 2011N/A3
Mar 2011N/A4
Apr 2011N/A4
May 2011N/A4
Jun 2011N/A4
Jul 2011N/A4
Aug 2011N/A4
Sep 2011N/A4

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A0
Nov 2010N/A3
Dec 2010N/A8
Jan 2011N/A12
Feb 2011N/A14
Mar 2011N/A15
Apr 2011N/A18
May 2011N/A20
Jun 2011N/A23
Jul 2011N/A24
Aug 2011N/A27
Sep 2011N/A32

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.