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FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway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

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

Clinic

Clinic Relationship Provider IT

New Technologies and 3D Imaging — “The Virtual Microscope”

CDOCS

APRIL 7, 2021

This entails that I implement products that have been researched with scientific evidence and are proven as clinically viable. As an endodontic specialist, patients have higher expectations when visiting my practice, so I feel the need to go above and beyond to provide quality treatment.

Treatment Plan

Treatment Plan Patients IT Consulting

Primary Care Digest

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

New Technologies and 3D Imaging — “The Virtual Microscope”

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