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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 March 31, 2014.

Fiscal Year - 2011

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TimeTargetNumber of Reviews
Oct 2010N/A24
Nov 2010N/A47
Dec 2010N/A54
Jan 2011N/A21
Feb 2011N/A38
Mar 2011N/A44
Apr 2011N/A42
May 2011N/A16
Jun 2011N/A45
Jul 2011N/A16
Aug 2011N/A23
Sep 2011N/A41

FY 2011 Total: 411

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

Fiscal Year - 2011
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TimeTargetNumber of Reviews
Oct 2010N/A18
Nov 2010N/A36
Dec 2010N/A45
Jan 2011N/A18
Feb 2011N/A30
Mar 2011N/A32
Apr 2011N/A33
May 2011N/A13
Jun 2011N/A29
Jul 2011N/A14
Aug 2011N/A20
Sep 2011N/A31

FY 2011 Total: 319

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

Fiscal Year - 2011
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TimeTargetNumber of Reviews
Oct 2010N/A6
Nov 2010N/A11
Dec 2010N/A9
Jan 2011N/A3
Feb 2011N/A8
Mar 2011N/A12
Apr 2011N/A9
May 2011N/A3
Jun 2011N/A16
Jul 2011N/A2
Aug 2011N/A3
Sep 2011N/A10

FY 2011 Total: 92

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.