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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 - 2011

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TimeTargetPercentage
Oct 201090100
Nov 201090100
Dec 20109098
Jan 201190100
Feb 201190100
Mar 201190100
Apr 201190100
May 201190100
Jun 201190100
Jul 201190100
Aug 201190100
Sep 201190100

FY 2011 Overall: 100%

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

Fiscal Year - 2011
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TimeTargetNumber of Reviews
Oct 2010N/A24
Nov 2010N/A47
Dec 2010N/A53
Jan 2011N/A21
Feb 2011N/A38
Mar 2011N/A44
Apr 2011N/A25
May 2011N/A16
Jun 2011N/A45
Jul 2011N/A16
Aug 2011N/A23
Sep 2011N/A41

FY 2011 Total: 410

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.