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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 - 2010

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TimeTargetNumber of Reviews
Oct 2009N/A25
Nov 2009N/A22
Dec 2009N/A28
Jan 2010N/A10
Feb 2010N/A22
Mar 2010N/A32
Apr 2010N/A30
May 2010N/A28
Jun 2010N/A28
Jul 2010N/A8
Aug 2010N/A31
Sep 2010N/A45

FY 2010 Total: 309

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

Fiscal Year - 2010
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TimeTargetNumber of Reviews
Oct 2009N/A20
Nov 2009N/A17
Dec 2009N/A15
Jan 2010N/A9
Feb 2010N/A19
Mar 2010N/A27
Apr 2010N/A25
May 2010N/A25
Jun 2010N/A19
Jul 2010N/A6
Aug 2010N/A23
Sep 2010N/A35

FY 2010 Total: 240

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

Fiscal Year - 2010
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TimeTargetNumber of Reviews
Oct 2009N/A5
Nov 2009N/A5
Dec 2009N/A13
Jan 2010N/A1
Feb 2010N/A3
Mar 2010N/A5
Apr 2010N/A5
May 2010N/A3
Jun 2010N/A9
Jul 2010N/A2
Aug 2010N/A8
Sep 2010N/A10

FY 2010 Total: 69

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.