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U.S. Department of Health and Human Services

About FDA

Percentage of orphan drug designation reviews completed in 90 days or less

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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TimeTargetPercentage
Oct 201175100
Nov 20117589
Dec 20117585
Jan 20127576
Feb 20127566
Mar 20127580
Apr 20127587
May 20127586
Jun 20127567
Jul 20127587
Aug 201275100
Sep 20127587

FY 2012 Overall: 83%

Total number of orphan drug designation reviews completed in 90 days or less

Fiscal Year - 2012
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TimeTargetNumber of Reviews
Oct 2011N/A26
Nov 2011N/A17
Dec 2011N/A28
Jan 2012N/A13
Feb 2012N/A25
Mar 2012N/A41
Apr 2012N/A20
May 2012N/A18
Jun 2012N/A20
Jul 2012N/A45
Aug 2012N/A18
Sep 2012N/A45

FY 2012 Total: 316

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.