FDA releases prescription user fee plan

WASHINGTON The Food and Drug Administration has released its Prescription Drug User Fee Act IV Information Technology Plan, according to published reports.

The agency’s intent is to provide regulated industry and other stakeholders with information on its vision for improving the automation of business processes and maintaining information technology systems that support the review of human drug applications.

The Food and Drug Administration Amendments Act of 2007 was enacted in September and reauthorized the Prescription Drug User Fee Act, which shortens the approval time for new drug and biologics approvals, among other changes in agency operations. The new law also includes information technology goals to support upgrading FDA’s drug safety program in four categories: objectives; communications and technical interactions; standards and information technology plan; and metrics and measures.