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 - 2013
| Time | Fiscal Year Target | Percent |
|---|---|---|
| Oct 2012 | 90 | 100 |
| Nov 2012 | 90 | 100 |
| Dec 2012 | 90 | 100 |
| Jan 2013 | 90 | 100 |
| Feb 2013 | 90 | 100 |
| Mar 2013 | 90 | TBD |
| Apr 2013 | 90 | TBD |
| May 2013 | 90 | TBD |
| Jun 2013 | 90 | TBD |
| Jul 2013 | 90 | TBD |
| Aug 2013 | 90 | TBD |
| Sep 2013 | 90 | TBD |
FY 2013 YTD: 100%
Number of designation submissions reviewed within the month that were acted on within 100 days
Fiscal Year - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 3 |
| Nov 2012 | N/A | 3 |
| Dec 2012 | N/A | 5 |
| Jan 2013 | N/A | 1 |
| Feb 2013 | N/A | 10 |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 22
Number of designation submissions reviewed and acted on within the month
Fiscal Year - 2013
| Time | Fiscal Year Target | Number |
|---|---|---|
| Oct 2012 | N/A | 3 |
| Nov 2012 | N/A | 3 |
| Dec 2012 | N/A | 5 |
| Jan 2013 | N/A | 1 |
| Feb 2013 | N/A | 10 |
| Mar 2013 | N/A | TBD |
| Apr 2013 | N/A | TBD |
| May 2013 | N/A | TBD |
| Jun 2013 | N/A | TBD |
| Jul 2013 | N/A | TBD |
| Aug 2013 | N/A | TBD |
| Sep 2013 | N/A | TBD |
FY 2013 YTD: 22
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.
