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
Annual Target: 20%
| Time | Target | Percent |
|---|---|---|
| Oct 2009 | N/A | 0 |
| Nov 2009 | N/A | 20 |
| Dec 2009 | N/A | 10 |
| Jan 2010 | N/A | 10 |
| Feb 2010 | N/A | 18 |
| Mar 2010 | N/A | 13 |
| Apr 2010 | N/A | 17 |
| May 2010 | N/A | 16 |
| Jun 2010 | N/A | 15 |
| Jul 2010 | N/A | 21 |
| Aug 2010 | N/A | 21 |
| Sep 2010 | N/A | 21 |
Number of NDAs for NMEs containing QbD elements received. Cumulative total reported for the Fiscal Year.
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 0 |
| Nov 2009 | N/A | 1 |
| Dec 2009 | N/A | 1 |
| Jan 2010 | N/A | 1 |
| Feb 2010 | N/A | 2 |
| Mar 2010 | N/A | 2 |
| Apr 2010 | N/A | 3 |
| May 2010 | N/A | 3 |
| Jun 2010 | N/A | 3 |
| Jul 2010 | N/A | 5 |
| Aug 2010 | N/A | 5 |
| Sep 2010 | N/A | 5 |
Number of NDAs for NMEs received in the month. Cumulative total reported for the Fiscal Year
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 3 |
| Nov 2009 | N/A | 5 |
| Dec 2009 | N/A | 10 |
| Jan 2010 | N/A | 10 |
| Feb 2010 | N/A | 11 |
| Mar 2010 | N/A | 15 |
| Apr 2010 | N/A | 18 |
| May 2010 | N/A | 19 |
| Jun 2010 | N/A | 20 |
| Jul 2010 | N/A | 24 |
| Aug 2010 | N/A | 24 |
| Sep 2010 | N/A | 24 |
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.
