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Number of written Chemistry, Manufacturing, and Controls (CMC) reviews for Investigational New Drugs (INDs) completed by ONDQA during the month (1)
Dictionary: An IND is an Investigational New Drug Application submitted to the FDA to request permission to conduct U.S. clinical trials using investigational drugs. ONDQA reviews the manufacturing and quality information submitted in new INDs and IND amendments with regards to patient safety and drug development. These reviews include all 30-day safety reviews, reviews of amendments, annual reports, and summary reviews.
This measure 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 - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 114 |
| Nov 2011 | N/A | 133 |
| Dec 2011 | N/A | 121 |
| Jan 2012 | N/A | TBD |
| Feb 2012 | N/A | TBD |
| Mar 2012 | N/A | TBD |
| Apr 2012 | N/A | TBD |
| May 2012 | N/A | TBD |
| Jun 2012 | N/A | TBD |
| Jul 2012 | N/A | TBD |
| Aug 2012 | N/A | TBD |
| Sep 2012 | N/A | TBD |
FY 2012 YTD: 368
Footnotes
- (1) Includes all 30-day safety reviews, reviews of amendments and annual reports, and summary reviews.
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.
