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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 - 2012

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TimeTargetPercentage
Oct 201190100
Nov 201190100
Dec 20119091
Jan 201290100
Feb 20129087
Mar 20129098
Apr 201290100
May 201290100
Jun 20129090
Jul 20129096
Aug 201290100
Sep 20129098

FY 2012 YTD: 96%

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

Fiscal Year - 2012
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TimeTargetNumber of Reviews
Oct 2011N/A26
Nov 2011N/A19
Dec 2011N/A30
Jan 2012N/A17
Feb 2012N/A33
Mar 2012N/A50
Apr 2012N/A23
May 2012N/A21
Jun 2012N/A27
Jul 2012N/A50
Aug 2012N/A18
Sep 2012N/A51

FY 2012 YTD: 365

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.