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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 - 2011

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Oct 2010N/A0
Nov 2010N/A18
Dec 2010N/A14
Jan 2011N/A7
Feb 2011N/A18
Mar 2011N/A17
Apr 2011N/A12
May 2011N/A0
Jun 2011N/A16
Jul 2011N/A0
Aug 2011N/A9
Sep 2011N/A5

FY 2011 Total: 116


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.