FDA sets up fee-based application process for veterinary medicines

The Food and Drug Administration has unveiled a Web-based notification system that lets the agency’s Center for Veterinary Medicine more efficiently receive and process approval applications for new drugs for animals.

In December 2003 Congress passed the Animal Drug User Fee Act, which created user fees that pharmaceutical companies pay when submitting an animal drug application. This new system administers those fees and automates all the activities related to the filed applications, including the opportunity for applicants to review their status online.

ADUFA also established performance standards for the CVM that are intended to reduce delays in product approvals. The system is expected to reduce the time it takes to initiate a drug review. By increasing the efficiency of the system and improving management of the fees, CVM plans to fund 60 additional product reviewers, a 50 percent increase in review personnel.

Switching to the user fee system is part of the FDA’s strategic initiative to modernize its finances, in part by integrating the system with banks’ electronic lockboxes and the agency’s financial system. Based on the success of the ADUFA system, the agency plans to convert other programs’ user fees to the new system in the coming months.

The new system was created by Unisys Corp. in less than three months, a company spokeswoman said.

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