By Scott Gottlieb (original source Health Affairs)
“In recent years, considerable bipartisan Congressional action, leadership from both Democratic and Republican administrations, and broad-based multistakeholder collaborations have focused on improving the tools and regulatory processes at the Food and Drug Administration (FDA), other government agencies, and public-private collaborations to support more efficient and timely development of new medical technologies. Enhanced funding through user fees and the bipartisan Twenty-First Century Cures legislation have supported a robust and better-resourced FDA and enabled science-driven collaborations in a range of areas including innovative clinical trials, “patient-focused” drug development, and greater clarity around standards for regulatory approval of new technologies.”
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