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 February 28, 2013.
Fiscal Year - 2012
| Time | Fiscal Year Target | Percent |
|---|---|---|
| Oct 2011 | 90 | 100 |
| Nov 2011 | 90 | 100 |
| Dec 2011 | 90 | 100 |
| Jan 2012 | 90 | 100 |
| Feb 2012 | 90 | 100 |
| Mar 2012 | 90 | 100 |
| Apr 2012 | 90 | 100 |
| May 2012 | 90 | 100 |
| Jun 2012 | 90 | 100 |
| Jul 2012 | 90 | 100 |
| Aug 2012 | 90 | 100 |
| Sep 2012 | 90 | 100 |
FY 2012 Overall: 100%
Number of designation submissions reviewed within the month that were acted on within 100 days
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 11 |
| Nov 2011 | N/A | 2 |
| Dec 2011 | N/A | 8 |
| Jan 2012 | N/A | 2 |
| Feb 2012 | N/A | 7 |
| Mar 2012 | N/A | 3 |
| Apr 2012 | N/A | 3 |
| May 2012 | N/A | 3 |
| Jun 2012 | N/A | 10 |
| Jul 2012 | N/A | 4 |
| Aug 2012 | N/A | 5 |
| Sep 2012 | N/A | 8 |
FY 2012 Total: 66
Number of designation submissions reviewed and acted on within the month
Fiscal Year - 2012
| Time | Target | Number |
|---|---|---|
| Oct 2011 | N/A | 11 |
| Nov 2011 | N/A | 2 |
| Dec 2011 | N/A | 8 |
| Jan 2012 | N/A | 2 |
| Feb 2012 | N/A | 7 |
| Mar 2012 | N/A | 3 |
| Apr 2012 | N/A | 3 |
| May 2012 | N/A | 3 |
| Jun 2012 | N/A | 10 |
| Jul 2012 | N/A | 4 |
| Aug 2012 | N/A | 5 |
| Sep 2012 | N/A | 8 |
FY 2012 Total: 66
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.
