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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 - 2011

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TimeTargetPercentage
Oct 20107596
Nov 20107594
Dec 20107593
Jan 20117595
Feb 20117595
Mar 20117586
Apr 20117598
May 201175100
Jun 20117591
Jul 20117594
Aug 20117596
Sep 20117593

FY 2011 Overall: 93%

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

Fiscal Year - 2011
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TimeTargetNumber of Reviews
Oct 2010N/A23
Nov 2010N/A44
Dec 2010N/A50
Jan 2011N/A20
Feb 2011N/A36
Mar 2011N/A38
Apr 2011N/A41
May 2011N/A16
Jun 2011N/A41
Jul 2011N/A15
Aug 2011N/A22
Sep 2011N/A38

FY 2011 Total: 384

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.