FDA Law

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. Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.

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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. 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. Incentives to motivate better nutritional choices and increase physical fitness would be welcome.

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Appointment Vaccination Patient-Centered IT 116