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Number of genomics Investigational New Drug (IND) and New Drug Application (NDA)/Biologics License Application (BLA) reviews completed per month (1)
Dictionary: These totals reflect a composite number of genomic reviews completed per month for submissions including, but not limited to the following: a) Investigational New Drug (IND) submissions (including protocols, meeting packages, and clinical study reports), b) Biologics License Application (BLA) submissions, c) New Drug Application (NDA) submissions (including original applications, supplements, and post-marketing commitment/requirement reports), and d) Investigational Device Exemptions (IDEs).
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 | 12 |
| Nov 2011 | N/A | 8 |
| Dec 2011 | N/A | 10 |
| 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: 30
Footnotes
- (1) PDUFA reviews are captured by OND
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.
