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Chronic Disease

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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

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. Further, the recent approval of Kebilidi for AADC is likely to follow this approach, suggesting that FDA may be gaining some comfort with type of ICE-clinical benefit relationship.

Clinic

Clinic Relationship Provider IT

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

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.

Chronic Disease

Chronic Disease Government Chronic Condition Clinic

Primary Care Digest

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

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

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