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U.S. Department of Health and Human Services

About FDA

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 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 June 30, 2014.

Fiscal Year - 2014

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TimeTargetNumber of Reviews
Oct 2013N/A51
Nov 2013N/A35
Dec 2013N/A40
Jan 2014N/A27
Feb 2014N/A41
Mar 2014N/A28
Apr 2014N/A51
May 2014N/A44
Jun 2014N/A43
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 360

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

Fiscal Year - 2014
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TimeTargetNumber of Reviews
Oct 2013N/A43
Nov 2013N/A25
Dec 2013N/A29
Jan 2014N/A22
Feb 2014N/A31
Mar 2014N/A25
Apr 2014N/A45
May 2014N/A40
Jun 2014N/A35
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 295

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

Fiscal Year - 2014
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TimeTargetNumber of Reviews
Oct 2013N/A8
Nov 2013N/A10
Dec 2013N/A11
Jan 2014N/A5
Feb 2014N/A10
Mar 2014N/A3
Apr 2014N/A6
May 2014N/A4
Jun 2014N/A8
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 65

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.