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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 - 2012

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TimeTargetNumber of Reviews
Oct 2011N/A26
Nov 2011N/A19
Dec 2011N/A33
Jan 2012N/A17
Feb 2012N/A38
Mar 2012N/A51
Apr 2012N/A23
May 2012N/A21
Jun 2012N/A30
Jul 2012N/A52
Aug 2012N/A18
Sep 2012N/A52

FY 2012 Total: 380

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

Fiscal Year - 2012
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TimeTargetNumber of Reviews
Oct 2011N/A21
Nov 2011N/A15
Dec 2011N/A21
Jan 2012N/A15
Feb 2012N/A30
Mar 2012N/A34
Apr 2012N/A15
May 2012N/A14
Jun 2012N/A23
Jul 2012N/A34
Aug 2012N/A11
Sep 2012N/A39

FY 2012 Total: 272

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

Fiscal Year - 2012
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TimeTargetNumber of Reviews
Oct 2011N/A5
Nov 2011N/A4
Dec 2011N/A12
Jan 2012N/A2
Feb 2012N/A8
Mar 2012N/A17
Apr 2012N/A8
May 2012N/A7
Jun 2012N/A7
Jul 2012N/A18
Aug 2012N/A7
Sep 2012N/A13

FY 2012 Total: 108

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.