FDA Law Blog

JANUARY 12, 2025

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. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

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Clinic Relationship Provider IT 64

FDA Law Blog

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 Blog

NOVEMBER 18, 2024

Rates of chronic disease are high, as is obesity. Wise government officials will modulate their views as they learn new facts. Kennedy’s tag line is that he and Trump will “Make America Healthy Again.” This seems like a reasonable goal, as most people can probably agree that America is not healthy. To some degree.

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Appointment Vaccination Patient-Centered IT 116