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U.S. Department of Health and Human Services

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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 March 31, 2019.

Fiscal Year - 2019

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TimeTargetPercentage
Oct 2018N/A100
Nov 2018N/A100
Dec 2018N/A100
Jan 2019N/A100
Feb 2019N/A100
Mar 2019N/A100
Apr 2019N/ATBD
May 2019N/ATBD
Jun 2019N/ATBD
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 100%

Footnotes

  • OOPD began retracking this measure in April 2016.

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

Fiscal Year - 2019
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TimeTargetNumber of Reviews
Oct 2018N/A75
Nov 2018N/A49
Dec 2018N/A50
Jan 2019N/A40
Feb 2019N/A80
Mar 2019N/A47
Apr 2019N/ATBD
May 2019N/ATBD
Jun 2019N/ATBD
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 341

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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