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The Massachusetts Avenue of health reform

The Health Policy Exchange

In contrast to the personality-driven path that Lyndon Johnson took to navigate legislative obstacles to Medicare and Medicaid, former management consultant Mitt Romney charted a decidedly different course to expanding health insurance when he became governor of Massachusetts in 2003. It was one thing to ask drivers to buy car insurance.

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Lastly, the reforms enacted by FDORA required that FDA publish guidance on early consultation with FDA to identify novel surrogate or intermediate clinical endpoints, use of novel trials designs for postapproval studies, the expedited withdrawal procedures, and considerations related to the use of surrogate and intermediate clinical endpoints.

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