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U.S. Department of Health and Human Services

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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 March 31, 2016.

Fiscal Year - 2016

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TimeTargetPercentage
Oct 2015N/A100
Nov 2015N/A92
Dec 2015N/A58
Jan 2016N/A53
Feb 2016N/A42
Mar 2016N/A34
Apr 2016N/ATBD
May 2016N/ATBD
Jun 2016N/ATBD
Jul 2016N/ATBD
Aug 2016N/ATBD
Sep 2016N/ATBD

FY 2016 YTD: 59%

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

Fiscal Year - 2016
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TimeTargetNumber of Reviews
Oct 2015N/A36
Nov 2015N/A35
Dec 2015N/A33
Jan 2016N/A20
Feb 2016N/A30
Mar 2016N/A17
Apr 2016N/ATBD
May 2016N/ATBD
Jun 2016N/ATBD
Jul 2016N/ATBD
Aug 2016N/ATBD
Sep 2016N/ATBD

FY 2016 YTD: 171

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.

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