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Access For 21st Century Cures: Updating Medicare’s Approach To Coverage And Payment

Scott Gottlieb, M.D.

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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