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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 - 2011
Annual Target: 10%
| Time | Target | Percent |
|---|---|---|
| Oct 2010 | N/A | 0 |
| Nov 2010 | N/A | 6 |
| Dec 2010 | N/A | 10 |
| Jan 2011 | N/A | 10 |
| Feb 2011 | N/A | 8 |
| Mar 2011 | N/A | 8 |
| Apr 2011 | N/A | 7 |
| May 2011 | N/A | 6 |
| Jun 2011 | N/A | 6 |
| Jul 2011 | N/A | 6 |
| Aug 2011 | N/A | 6 |
| Sep 2011 | N/A | 5 |
Number of NDAs containing QbD elements received. Cumulative total reported each Fiscal Year.
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 0 |
| Nov 2010 | N/A | 1 |
| Dec 2010 | N/A | 3 |
| Jan 2011 | N/A | 4 |
| Feb 2011 | N/A | 4 |
| Mar 2011 | N/A | 5 |
| Apr 2011 | N/A | 5 |
| May 2011 | N/A | 5 |
| Jun 2011 | N/A | 5 |
| Jul 2011 | N/A | 5 |
| Aug 2011 | N/A | 6 |
| Sep 2011 | N/A | 6 |
Number of NDAs received. Cumulative total reported each Fiscal Year.
Fiscal Year - 2011
| Time | Target | Number |
|---|---|---|
| Oct 2010 | N/A | 5 |
| Nov 2010 | N/A | 16 |
| Dec 2010 | N/A | 31 |
| Jan 2011 | N/A | 41 |
| Feb 2011 | N/A | 50 |
| Mar 2011 | N/A | 60 |
| Apr 2011 | N/A | 71 |
| May 2011 | N/A | 77 |
| Jun 2011 | N/A | 86 |
| Jul 2011 | N/A | 90 |
| Aug 2011 | N/A | 100 |
| Sep 2011 | N/A | 113 |
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.
