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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 September 30, 2013.

Fiscal Year - 2013

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TimeTargetNumber of Reviews
Oct 2012N/A22
Nov 2012N/A23
Dec 2012N/A48
Jan 2013N/A36
Feb 2013N/A15
Mar 2013N/A40
Apr 2013N/A30
May 2013N/A44
Jun 2013N/A28
Jul 2013N/A24
Aug 2013N/A29
Sep 2013N/A55

FY 2013 Total: 394

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

Fiscal Year - 2013
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TimeTargetNumber of Reviews
Oct 2012N/A10
Nov 2012N/A13
Dec 2012N/A36
Jan 2013N/A30
Feb 2013N/A11
Mar 2013N/A31
Apr 2013N/A21
May 2013N/A29
Jun 2013N/A22
Jul 2013N/A17
Aug 2013N/A24
Sep 2013N/A38

FY 2013 Total: 282

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

Fiscal Year - 2013
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TimeTargetNumber of Reviews
Oct 2012N/A12
Nov 2012N/A10
Dec 2012N/A12
Jan 2013N/A6
Feb 2013N/A4
Mar 2013N/A9
Apr 2013N/A9
May 2013N/A15
Jun 2013N/A6
Jul 2013N/A7
Aug 2013N/A5
Sep 2013N/A16

FY 2013 Total: 111

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.