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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 - 2011

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TimeTargetNumber
Oct 2010N/A366
Nov 2010N/A269
Dec 2010N/A679
Jan 2011N/A762
Feb 2011N/A787
Mar 2011N/A856
Apr 2011N/A1,077
May 2011N/A925
Jun 2011N/A1,877
Jul 2011N/A1,271
Aug 2011N/A1,467
Sep 2011N/A945

FY 2011 Total: 11,291

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 - 2011

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TimeTargetNumber
Oct 2010N/A65
Nov 2010N/A49
Dec 2010N/A89
Jan 2011N/A66
Feb 2011N/A94
Mar 2011N/A99
Apr 2011N/A99
May 2011N/A81
Jun 2011N/A121
Jul 2011N/A115
Aug 2011N/A96
Sep 2011N/A105

FY 2011 Total: 1,079

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.