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Number of IND submissions and amendments evaluated and signed off within the month

Dictionary: Database tracking of the number of IND submissions and amendments, for therapeutic protein and monoclonal antibody products, evaluated and signed off by OBP within the month. These are submissions that have had an evaluation by OBP reviewers to ensure there are no issues that impact product quality and related safety concerns.


These measures have 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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TimeTargetNumber
Oct 2009N/A422
Nov 2009N/A895
Dec 2009N/A499
Jan 2010N/A291
Feb 2010N/A626
Mar 2010N/A641
Apr 2010N/A585
May 2010N/A531
Jun 2010N/A915
Jul 2010N/A463
Aug 2010N/A348
Sep 2010N/A562

Number of IND reviews completed and signed off within the month

Dictionary: Database tracking of the number IND reviews, for therapeutic protein and monoclonal antibody products, completed and signed off by OBP within the month. Includes all 30-day safety reviews, summary and executive reviews, and reviews of manufacturing changes and new study requests. These reviews support the quality and safety of investigational new drugs and significant manufacturing changes during development.

Fiscal Year - 2010

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TimeTargetNumber
Oct 2009N/A35
Nov 2009N/A51
Dec 2009N/A53
Jan 2010N/A48
Feb 2010N/A47
Mar 2010N/A66
Apr 2010N/A56
May 2010N/A58
Jun 2010N/A57
Jul 2010N/A37
Aug 2010N/A48
Sep 2010N/A54

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.