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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

JANUARY 12, 2025

Whether a surrogate or intermediate clinical endpoint (ICE), the endpoint to support accelerated approval is one that can be assessed more rapidly than the ultimate clinical benefit; this is what enables earlier patient access than would be possible while generating the evidence to support a traditional approval, which is typically infeasible.

Clinic

Clinic Relationship Provider IT

Guidelines or Goals in Heart Failure: A Podcast with Parag Goyal, Nicole Superville, and Matthew Shuster

GeriPal

OCTOBER 17, 2024

We talk about what is heart failure, particularly HFpEF, how we treat it (including the use of sodium–glucose cotransporter-2 inhibitors (SGLT2’s), and how we should apply guidelines to individual patients, especially those with multimorbidity who are taking a lot of other medications. When I see a patient? Matthew, I get the lyrics.

Primary Care

Primary Care Patient-Centered IT Patients

Primary Care Digest

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

Guidelines or Goals in Heart Failure: A Podcast with Parag Goyal, Nicole Superville, and Matthew Shuster

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