User fees, 'Cures,' elections: FDA bracing for the crash
This article was originally published in Scrip
Executive Summary
The FDA is facing a unique situation in which lawmakers are in the midst of revamping some of the agency's drug and device review and approval processes, while regulators have just launched the latest rounds of industry user fee negotiations, with it all expected to come to a head during the 2016 US presidential and congressional elections.
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