FDA Law Blog

JANUARY 12, 2025

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.

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FDA Law Blog

NOVEMBER 14, 2024

As crisply laid out in short YouTube video , MAHA aims to transform public health by zeroing in on “our nation’s biggest health challenge – chronic disease.” Undoubtedly, the public health and economic toll of chronic disease is staggering. Califf – several chronic diseases are diet-related.

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FDA Law Blog

JUNE 4, 2025

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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GeriPal

APRIL 14, 2022

So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. If somebody’s dealing with a chronic pain and multiple chronic diseases, they have an opioid use disorder and we get referred that patient to a palliative care clinic is that in our Bailey wick?

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Illness Patient-Centered IT Patients 102

Family Medicine Initiative

APRIL 10, 2024

Family medicine is neither the most prestigious nor the highest paid medical profession. You no longer need to review all medical records or repeat the whole medical and personal history. Adherence to medical advice improves and unnecessary self-referrals to other doctors decrease. Over time, more trust develops.

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FDA Law Blog

NOVEMBER 18, 2024

Rates of chronic disease are high, as is obesity. Though he did not mention it, there is also a Medical Device User Fee Act (MDUFA), which accounted for approximately 44% of the budget for the Center for Devices and Radiological Health (CDRH) in FY2023. Kennedy’s tag line is that he and Trump will “Make America Healthy Again.”

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Appointment Vaccination Patient-Centered IT 116