FDA Law

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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Clinic Relationship Provider IT 64

FDA Law

JUNE 4, 2025

Ordinarily, a public health initiative of such magnitude would have been governed by a transparent multi-step process featuring public meetings and drawing on external scientific expertise. In other words, as you read this, the Assessments findings and recommendations are getting baked into federal government policy, for better or worse.

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Chronic Disease Government Chronic Condition Clinic 59

FDA Law

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.”

Appointment 116

Appointment Vaccination Patient-Centered IT 116