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Number of New Bioequivalence Recommendations Posted in the month
Dictionary: The importance of bioequivalence recommendations is to make them available as quickly as possible for newly approved innovator products giving potential generic manufacturers ample time to begin to develop generic versions. By posting these recommendations publicly the agency is communicating to all interested persons at the same time on an equitable basis while also enabling transparency with the agency’s decision making.
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 | 3 |
| Nov 2011 | N/A | 6 |
| Dec 2011 | N/A | 0 |
| 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: 9
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.
