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U.S. Department of Health and Human Services

About FDA

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 - 2010

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Oct 2009N/A19
Nov 2009N/A17
Dec 2009N/A36
Jan 2010N/A0
Feb 2010N/A74
Mar 2010N/A28
Apr 2010N/A16
May 2010N/A20
Jun 2010N/A7
Jul 2010N/A15
Aug 2010N/A26
Sep 2010N/A13

FY 2010 Total: 271


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.