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U.S. Department of Health and Human Services

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Total number of orphan drug designation reviews completed in the month

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 and to allocate available resources appropriately. The target review percentages per the noted review periods will continue to provide quality service to OOPD orphan drug applicant customers.

Information is current as of September 30, 2020.

Fiscal Year - 2020

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TimeTargetNumber of Reviews
Oct 2019N/A58
Nov 2019N/A48
Dec 2019N/A58
Jan 2020N/A64
Feb 2020N/A50
Mar 2020N/A68
Apr 2020N/A69
May 2020N/A48
Jun 2020N/A87
Jul 2020N/A84
Aug 2020N/A77
Sep 2020N/A83

FY 2020 YTD: 794

Number of reviews of first-time orphan drug designation applications completed in the month

Fiscal Year - 2020
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TimeTargetNumber of Reviews
Oct 2019N/A45
Nov 2019N/A37
Dec 2019N/A45
Jan 2020N/A52
Feb 2020N/A46
Mar 2020N/A53
Apr 2020N/A51
May 2020N/A35
Jun 2020N/A65
Jul 2020N/A68
Aug 2020N/A66
Sep 2020N/A76

FY 2020 YTD: 639

Number of reviews of amended orphan drug designation applications completed in the month

Fiscal Year - 2020
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TimeTargetNumber of Reviews
Oct 2019N/A13
Nov 2019N/A11
Dec 2019N/A13
Jan 2020N/A12
Feb 2020N/A4
Mar 2020N/A15
Apr 2020N/A18
May 2020N/A13
Jun 2020N/A22
Jul 2020N/A16
Aug 2020N/A11
Sep 2020N/A7

FY 2020 YTD: 155

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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