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U.S. Department of Health and Human Services

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Total submissions routed to drug review

Dictionary: Total submissions routed to the drug review process provides a good summary of workload volume for CDER. Submissions are comprised primarily of New Drug Application (NDA) related submissions, Abbreviated New Drug Application (ANDA) related submissions and Investigational New Drug (IND) related submissions.


These measures 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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TimeTargetNumber
Oct 2009N/A14,751
Nov 2009N/A13,987
Dec 2009N/A14,763
Jan 2010N/A11,926
Feb 2010N/A13,365
Mar 2010N/A15,542
Apr 2010N/A15,478
May 2010N/A14,465
Jun 2010N/A15,795
Jul 2010N/A14,868
Aug 2010N/A15,386
Sep 2010N/A15,019

Total New Drug Application (NDA) related submissions

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A1,848
Nov 2009N/A1,889
Dec 2009N/A1,979
Jan 2010N/A1,519
Feb 2010N/A1,718
Mar 2010N/A1,932
Apr 2010N/A1,889
May 2010N/A1,971
Jun 2010N/A2,005
Jul 2010N/A1,891
Aug 2010N/A1,815
Sep 2010N/A1,790

Total Abbreviated New Drug Application (ANDA) related submissions

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A3,082
Nov 2009N/A2,797
Dec 2009N/A3,015
Jan 2010N/A2,705
Feb 2010N/A2,877
Mar 2010N/A3,522
Apr 2010N/A3,313
May 2010N/A2,769
Jun 2010N/A3,417
Jul 2010N/A2,959
Aug 2010N/A3,257
Sep 2010N/A3,296

Total Investigational New Drug (IND) related submissions

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A7,967
Nov 2009N/A7,555
Dec 2009N/A7,763
Jan 2010N/A6,104
Feb 2010N/A6,854
Mar 2010N/A8,031
Apr 2010N/A7,848
May 2010N/A7,618
Jun 2010N/A7,979
Jul 2010N/A7,783
Aug 2010N/A8,365
Sep 2010N/A7,903

Other submissions

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A1,854
Nov 2009N/A1,746
Dec 2009N/A2,006
Jan 2010N/A1,598
Feb 2010N/A1,916
Mar 2010N/A2,057
Apr 2010N/A2,428
May 2010N/A2,107
Jun 2010N/A2,394
Jul 2010N/A2,235
Aug 2010N/A1,949
Sep 2010N/A2,030

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.