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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 - 2012

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TimeTargetNumber
Oct 2011N/A15,835
Nov 2011N/A14,463
Dec 2011N/A15,671
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 45,969

Total New Drug Application (NDA) related submissions

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A2,509
Nov 2011N/A1,985
Dec 2011N/A2,132
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 6,626

Total Abbreviated New Drug Application (ANDA) related submissions

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A3,398
Nov 2011N/A2,723
Dec 2011N/A2,847
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 8,968

Total Investigational New Drug (IND) related submissions

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A7,499
Nov 2011N/A7,188
Dec 2011N/A7,599
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 22,286

Other submissions

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A2,429
Nov 2011N/A2,567
Dec 2011N/A3,093
Jan 2012N/ATBD
Feb 2012N/ATBD
Mar 2012N/ATBD
Apr 2012N/ATBD
May 2012N/ATBD
Jun 2012N/ATBD
Jul 2012N/ATBD
Aug 2012N/ATBD
Sep 2012N/ATBD

FY 2012 YTD: 8,089

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.