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U.S. Department of Health and Human Services

About FDA

Percentage of orphan drug designation reviews completed in 120 days or less

Dictionary: OOPD will track the time it takes to complete the review of each Orphan Drug designation application. OOPD’s goal is to provide all applicants with a complete and comprehensive review in a timely manner by monitoring the incoming workload and allocating resources as needed. The target review percentages per the noted review periods will continue to ensure high quality service to OOPD orphan drug applicant customers.

Information is current as of December 31, 2012.

Fiscal Year - 2013

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TimeTargetPercentage
Oct 201290100
Nov 20129096
Dec 201290100
Jan 201390TBD
Feb 201390TBD
Mar 201390TBD
Apr 201390TBD
May 201390TBD
Jun 201390TBD
Jul 201390TBD
Aug 201390TBD
Sep 201390TBD

FY 2013 YTD: 99%

Total number of orphan drug designation reviews completed in 120 days or less

Fiscal Year - 2013
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TimeTargetNumber of Reviews
Oct 2012N/A22
Nov 2012N/A22
Dec 2012N/A48
Jan 2013N/ATBD
Feb 2013N/ATBD
Mar 2013N/ATBD
Apr 2013N/ATBD
May 2013N/ATBD
Jun 2013N/ATBD
Jul 2013N/ATBD
Aug 2013N/ATBD
Sep 2013N/ATBD

FY 2013 YTD: 92

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.