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

About FDA

Percentage of designation submissions reviewed and acted on within 100 days

Dictionary: Designation provides drug companies with incentives. Upon approval or conditional approval of a product, designation provides sponsors with seven years of exclusive marketing rights and an opportunity to apply for grants. A drug company submits a request to OMUMS for a drug to be designated for a specific use. After the designation request is granted, no other identical designation may be granted. However, more than one designation can be granted for the same drug, as long as the designations are for different dosage forms or different intended uses. Designation requires that the drug company actively work toward approval and provide annual reports to OMUMS to show due diligence. Once a drug company receives a drug designation, the company or other organizations or individuals working with the company are eligible for grants through the federal government. This grant money is used to reduce the cost of conducting safety and effectiveness studies.

Information is current as of December 31, 2013.

Fiscal Year - 2010

Skip graphic and jump to text data

TimeFiscal Year TargetPercent
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 201090100
Feb 201090-
Mar 20109089
Apr 201090100
May 20109083
Jun 201090100
Jul 201090100
Aug 201090100
Sep 201090100

FY 2010 Overall: 92

Number of designation submissions reviewed within the month that were acted on within 100 days

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

TimeTargetNumber
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 2010N/A5
Feb 2010N/A0
Mar 2010N/A8
Apr 2010N/A3
May 2010N/A15
Jun 2010N/A6
Jul 2010N/A2
Aug 2010N/A3
Sep 2010N/A2

FY 2010 Total: 44

Number of designation submissions reviewed and acted on within the month

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

TimeTargetNumber
Oct 2009N/AN/A
Nov 2009N/AN/A
Dec 2009N/AN/A
Jan 2010N/A5
Feb 2010N/A0
Mar 2010N/A9
Apr 2010N/A3
May 2010N/A18
Jun 2010N/A6
Jul 2010N/A2
Aug 2010N/A3
Sep 2010N/A2

FY 2010 Total: 48

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.