User Fee Management In CDER Plans To Enhance IT Capabilities
This article was originally published in The Tan Sheet
The need to assimilate biosimilar and generic drug user fee programs and a quest for greater efficiency are major drivers of the center’s proposed $88.9 million spending plan on information technology systems in fiscal year 2014.
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FDA’s $4.7 billion fiscal 2014 budget request proposes new fees including $58.9 million from food establishment registrations and inspections, $19.1 million from cosmetics firms and $15.04 million from medical product reinspections.
The agency has not been able to get rid of outdated IT systems despite spending more than $160 million to date on a program designed to do that among other goals.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.