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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 - 2013

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TimeTargetPercentage
Oct 20127577
Nov 20127583
Dec 20127588
Jan 20137592
Feb 20137580
Mar 20137598
Apr 20137598
May 20137598
Jun 20137598
Jul 201375100
Aug 20137590
Sep 20137585

FY 2013 Overall: 91%

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

Fiscal Year - 2013
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TimeTargetNumber of Reviews
Oct 2012N/A17
Nov 2012N/A19
Dec 2012N/A42
Jan 2013N/A33
Feb 2013N/A12
Mar 2013N/A39
Apr 2013N/A29
May 2013N/A43
Jun 2013N/A27
Jul 2013N/A24
Aug 2013N/A26
Sep 2013N/A47

FY 2013 Total: 358

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.