• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Percentage of orphan drug designation reviews completed in 120 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 December 31, 2012.

Fiscal Year - 2010

Skip graphic and jump to text data

TimeTargetPercentage
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 20099093
Jan 201090100
Feb 20109082
Mar 20109094
Apr 201090100
May 20109096
Jun 20109096
Jul 20109088
Aug 20109097
Sep 201090100

FY 2010 10-Month Overall: 81%

Total number of orphan drug designation reviews completed in 120 days or less

Fiscal Year - 2010
Skip graphic and jump to text data.

TimeTargetNumber of Reviews
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/A26
Jan 2010N/A10
Feb 2010N/A18
Mar 2010N/A30
Apr 2010N/A30
May 2010N/A27
Jun 2010N/A27
Jul 2010N/A7
Aug 2010N/A30
Sep 2010N/A45

FY 2010 10-Month Total: 250

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.