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U.S. Department of Health and Human Services

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Total number of orphan drug designation requests received in the month

Dictionary: OOPD will track the number of original Orphan Drug designation applications received each month. OOPD’s goal is to inform all stakeholders about this aspect of the incoming workload.

Information is current as of March 31, 2019.

Fiscal Year - 2019

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TimeTargetNumber of Requests
Oct 2018N/A50
Nov 2018N/A53
Dec 2018N/A68
Jan 2019N/A53
Feb 2019N/A57
Mar 2019N/A44
Apr 2019N/ATBD
May 2019N/ATBD
Jun 2019N/ATBD
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 325

Footnotes

  • This measure started being tracked in April 2016.

Number of first-time orphan drug designation requests received in the month

Fiscal Year - 2019
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TimeTargetNumber of Requests
Oct 2018N/A37
Nov 2018N/A39
Dec 2018N/A59
Jan 2019N/A42
Feb 2019N/A44
Mar 2019N/A29
Apr 2019N/ATBD
May 2019N/ATBD
Jun 2019N/ATBD
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 250

Number of amended orphan drug designation requests received in the month

Fiscal Year - 2019
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TimeTargetNumber of Requests
Oct 2018N/A13
Nov 2018N/A14
Dec 2018N/A9
Jan 2019N/A11
Feb 2019N/A13
Mar 2019N/A15
Apr 2019N/ATBD
May 2019N/ATBD
Jun 2019N/ATBD
Jul 2019N/ATBD
Aug 2019N/ATBD
Sep 2019N/ATBD

FY 2019 YTD: 75

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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