About FDA
Percent of NDA related submissions in eCTD format in the month
Dictionary: The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information based on internationally recognized standards. eCTD is the preferred format for electronic submissions.
These measures has 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
| Time | Target | Percent |
|---|---|---|
| Oct 2009 | N/A | 60 |
| Nov 2009 | N/A | 59 |
| Dec 2009 | N/A | 58 |
| Jan 2010 | N/A | 62 |
| Feb 2010 | N/A | 59 |
| Mar 2010 | N/A | 61 |
| Apr 2010 | N/A | 64 |
| May 2010 | N/A | 66 |
| Jun 2010 | N/A | 64 |
| Jul 2010 | N/A | 65 |
| Aug 2010 | N/A | 65 |
| Sep 2010 | N/A | 65 |
Total New Drug Application (NDA) related submissions
Fiscal Year - 2010
| Time | Target | Number |
|---|---|---|
| Oct 2009 | N/A | 1,848 |
| Nov 2009 | N/A | 1,889 |
| Dec 2009 | N/A | 1,979 |
| Jan 2010 | N/A | 1,519 |
| Feb 2010 | N/A | 1,718 |
| Mar 2010 | N/A | 1,932 |
| Apr 2010 | N/A | 1,889 |
| May 2010 | N/A | 1,971 |
| Jun 2010 | N/A | 2,005 |
| Jul 2010 | N/A | 1,891 |
| Aug 2010 | N/A | 1,815 |
| Sep 2010 | N/A | 1,790 |
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.
