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Number of submissions with electronic datasets reaching mid-cycle review during the month
Measure was implemented starting April 2010
Dictionary: 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
Measure was implemented starting April 2010
| Time | Target | Number |
|---|---|---|
| Apr 2010 | N/A | 8 |
| May 2010 | N/A | 17 |
| Jun 2010 | N/A | 13 |
| Jul 2010 | N/A | 4 |
| Aug 2010 | N/A | 15 |
| Sep 2010 | N/A | 12 |
Percent of submissions reaching mid-cycle review during the month that required minimal or no additional data management prior to performing analyses and no requests for additional datasets were made to sponsor
Measure was implemented starting April 2010
Fiscal Year - 2010
Measure was implemented starting April 2010
| Time | Target | Percent |
|---|---|---|
| Apr 2010 | N/A | 25 |
| May 2010 | N/A | 47 |
| Jun 2010 | N/A | 61 |
| Jul 2010 | N/A | 50 |
| Aug 2010 | N/A | 73 |
| Sep 2010 | N/A | 58 |
Percent of submissions reaching mid-cycle review during the month that required additional data management prior to performing analyses, but no requests for additional datasets were made to the sponsor
Measure was implemented starting April 2010
Fiscal Year - 2010
Measure was implemented starting April 2010
| Time | Target | Percent |
|---|---|---|
| Apr 2010 | N/A | 50 |
| May 2010 | N/A | 24 |
| Jun 2010 | N/A | 31 |
| Jul 2010 | N/A | 25 |
| Aug 2010 | N/A | 20 |
| Sep 2010 | N/A | 17 |
Percent of submissions reaching mid-cycle review during the month that required additional data requests to sponsor for adequate analysis datasets
Measure was implemented starting April 2010
Fiscal Year - 2010
Measure was implemented starting April 2010
| Time | Target | Percent |
|---|---|---|
| Apr 2010 | N/A | 25 |
| May 2010 | N/A | 29 |
| Jun 2010 | N/A | 8 |
| Jul 2010 | N/A | 25 |
| Aug 2010 | N/A | 7 |
| Sep 2010 | N/A | 25 |
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.
