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U.S. Department of Health and Human Services

About FDA

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.

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 - 2012

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TimeTargetPercent
Oct 2011N/A50
Nov 2011N/A29
Dec 2011N/A14
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

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

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A3
Nov 2011N/A4
Dec 2011N/A5
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

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

Fiscal Year - 2012
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2011N/A6
Nov 2011N/A14
Dec 2011N/A37
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

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.