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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 December 31, 2014.

Fiscal Year - 2015

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TimeTargetPercentage
Oct 20147595
Nov 20147594
Dec 20147597
Jan 201575TBD
Feb 201575TBD
Mar 201575TBD
Apr 201575TBD
May 201575TBD
Jun 201575TBD
Jul 201575TBD
Aug 201575TBD
Sep 201575TBD

FY 2015 YTD: 95%

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

Fiscal Year - 2015
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TimeTargetNumber of Reviews
Oct 2014N/A62
Nov 2014N/A51
Dec 2014N/A34
Jan 2015N/ATBD
Feb 2015N/ATBD
Mar 2015N/ATBD
Apr 2015N/ATBD
May 2015N/ATBD
Jun 2015N/ATBD
Jul 2015N/ATBD
Aug 2015N/ATBD
Sep 2015N/ATBD

FY 2015 YTD: 147

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.