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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance. As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority.

Clinic 64
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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog

The Strategy must address appropriately restructuring the Federal Governments response to the childhood chronic disease crisis, including by ending Federal practices that exacerbate the health crisis or unsuccessfully attempt to address it, and by adding powerful new solutions that will end childhood chronic disease.

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8 Reasons Why Family Physicians are the Actual Stars of Medicine

Family Medicine Initiative

Family medicine is neither the most prestigious nor the highest paid medical profession. This graph illustrates that the benefit of long-term GP-patient relationships is even dose-dependent (longer GP-patient-relationship = lower risk of dying prematurely): Why do long-term GP-patient relationships improve health and reduce costs?