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U.S. Department of Health and Human Services

About FDA

Percentage of orphan drug designation reviews completed in 90 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 September 30, 2013.

Fiscal Year - 2010

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TimeTargetPercentage
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 20097082
Jan 20107080
Feb 20107082
Mar 20107081
Apr 20107097
May 20107086
Jun 20107079
Jul 20107075
Aug 20107077
Sep 20107096

FY 2010 Overall: 72%

Total number of orphan drug designation reviews completed in 90 days or less

Fiscal Year - 2010
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TimeTargetNumber of Reviews
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/A23
Jan 2010N/A8
Feb 2010N/A18
Mar 2010N/A26
Apr 2010N/A29
May 2010N/A24
Jun 2010N/A22
Jul 2010N/A6
Aug 2010N/A24
Sep 2010N/A43

FY 2010 10-Month Total: 223

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.