August 1, 2011
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees (PDUFA) for fiscal year (FY) 2012. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products
This document establishes fee rates for FY 2012 for application fees for an application requiring:
• For an application not requiring clinical data or a supplement requiring clinical data ($920,750)
• For establishment fees ($520,100)
• For product fees ($98,970)
These fees are effective on October 1, 2011, and will remain in effect through September 30, 2012.
The FDA is also announcing the fee rates and payment procedures for medical device user fees (MDUFA) for fiscal year (FY) 2012.The FD&C Act, authorizes FDA to collect user fees for certain medical device submissions, and annual fees for certain periodic reports and for certain establishments subject to registration.
These fees apply from October 1, 2011, through September 30, 2012. This document provides information on how the fees for FY 2012 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Both PDUFA and MDUFA will be renewed in (FY) 2012.
For more information on PDUFA, please visit the following site:
For more information on MDUFA, please visit the following site: