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U.S. Department of Health and Human Services

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Percentage of meetings with sponsors that include discussion of Quality by Design (QbD) information. 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), New Drug Application (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/A-
Nov 2009N/A-
Dec 2009N/A100
Jan 2010N/A50
Feb 2010N/A33
Mar 2010N/A50
Apr 2010N/A50
May 2010N/A50
Jun 2010N/A50
Jul 2010N/A40
Aug 2010N/A33
Sep 2010N/A27

Number of meetings with sponsors that included discussion of QbD information. Cumulative total reported for the Fiscal Year. (1)

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A0
Nov 2009N/A0
Dec 2009N/A1
Jan 2010N/A1
Feb 2010N/A1
Mar 2010N/A2
Apr 2010N/A2
May 2010N/A3
Jun 2010N/A4
Jul 2010N/A4
Aug 2010N/A4
Sep 2010N/A4

Footnotes

  • (1) Includes cancelled meetings where preliminary responses were sent

Number of meetings with sponsors. Cumulative total reported for the Fiscal Year. (1)

Fiscal Year - 2010
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2009N/A0
Nov 2009N/A0
Dec 2009N/A1
Jan 2010N/A2
Feb 2010N/A3
Mar 2010N/A4
Apr 2010N/A4
May 2010N/A6
Jun 2010N/A8
Jul 2010N/A10
Aug 2010N/A12
Sep 2010N/A15

Footnotes

  • (1) Includes cancelled meetings where preliminary responses were sent.

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.