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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 - 2011

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TimeTargetNumber
Oct 2010N/A14,633
Nov 2010N/A14,312
Dec 2010N/A15,508
Jan 2011N/A14,183
Feb 2011N/A15,282
Mar 2011N/A17,080
Apr 2011N/A15,651
May 2011N/A15,838
Jun 2011N/A15,944
Jul 2011N/A15,286
Aug 2011N/A16,273
Sep 2011N/A15,755

FY 2011 Total: 185,745

Total New Drug Application (NDA) related submissions

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A1,820
Nov 2010N/A1,791
Dec 2010N/A2,158
Jan 2011N/A1,526
Feb 2011N/A1,932
Mar 2011N/A1,931
Apr 2011N/A1,930
May 2011N/A2,116
Jun 2011N/A2,010
Jul 2011N/A1,914
Aug 2011N/A1,916
Sep 2011N/A2,137

FY 2011 Total: 23,181

Total Abbreviated New Drug Application (ANDA) related submissions

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A3,030
Nov 2010N/A2,974
Dec 2010N/A3,118
Jan 2011N/A3,281
Feb 2011N/A3,372
Mar 2011N/A3,573
Apr 2011N/A3,674
May 2011N/A3,869
Jun 2011N/A3,626
Jul 2011N/A3,531
Aug 2011N/A3,576
Sep 2011N/A3,416

FY 2011 Total: 41,040

Total Investigational New Drug (IND) related submissions

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A7,829
Nov 2010N/A7,754
Dec 2010N/A7,819
Jan 2011N/A6,851
Feb 2011N/A7,518
Mar 2011N/A8,738
Apr 2011N/A7,735
May 2011N/A7,409
Jun 2011N/A7,884
Jul 2011N/A7,475
Aug 2011N/A8,193
Sep 2011N/A7,725

FY 2011 Total: 92,930

Other submissions

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A1,954
Nov 2010N/A1,793
Dec 2010N/A2,413
Jan 2011N/A2,525
Feb 2011N/A2,460
Mar 2011N/A2,838
Apr 2011N/A2,312
May 2011N/A2,444
Jun 2011N/A2,424
Jul 2011N/A2,366
Aug 2011N/A2,588
Sep 2011N/A2,477

FY 2011 Total: 28,594

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.