• 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 - 2014

Skip graphic and jump to text data

TimeFiscal Year TargetPercent
Oct 201390100
Nov 201390100
Dec 201390100
Jan 201490TBD
Feb 201490TBD
Mar 201490TBD
Apr 201490TBD
May 201490TBD
Jun 201490TBD
Jul 201490TBD
Aug 201490TBD
Sep 201490TBD

FY 2014 YTD: 100%

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

Fiscal Year - 2014
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2013N/A2
Nov 2013N/A5
Dec 2013N/A3
Jan 2014N/ATBD
Feb 2014N/ATBD
Mar 2014N/ATBD
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 10

Number of designation submissions reviewed and acted on within the month

Fiscal Year - 2014
Skip graphic and jump to text data.

TimeTargetNumber
Oct 2013N/A2
Nov 2013N/A5
Dec 2013N/A3
Jan 2014N/ATBD
Feb 2014N/ATBD
Mar 2014N/ATBD
Apr 2014N/ATBD
May 2014N/ATBD
Jun 2014N/ATBD
Jul 2014N/ATBD
Aug 2014N/ATBD
Sep 2014N/ATBD

FY 2014 YTD: 10

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.