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 November 30, 2012.

• FY 2010
• FY 2011
• FY 2012
• FY 2013
• All

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

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	0
Nov 2010	N/A	2
Dec 2010	N/A	2
Jan 2011	N/A	4
Feb 2011	N/A	5
Mar 2011	N/A	7
Apr 2011	N/A	2
May 2011	N/A	6
Jun 2011	N/A	5
Jul 2011	N/A	7
Aug 2011	N/A	8
Sep 2011	N/A	9

FY 2011 Total: 57

Number of designation submissions reviewed and acted on within the month

Fiscal Year - 2011

Time	Target	Number
Oct 2010	N/A	0
Nov 2010	N/A	2
Dec 2010	N/A	2
Jan 2011	N/A	4
Feb 2011	N/A	5
Mar 2011	N/A	7
Apr 2011	N/A	2
May 2011	N/A	7
Jun 2011	N/A	5
Jul 2011	N/A	7
Aug 2011	N/A	8
Sep 2011	N/A	9

FY 2011 Total: 58