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FDA’s New RWE Guidance Provides Recommendations for Sponsors Conducting Non-Interventional Real-World Studies and Describes the Potential to Use RWE for Initial Approvals in One Limited Circumstance

FDA Law Blog

SEPTEMBER 10, 2023

In contrast, as the guidance explains, a non-interventional study (also referred to as an observational study) is a type of study in which patients received the marketed drug of interest during routine medical practice and are not assigned to an intervention according to a protocol.

Provider

Provider Patient-Centered Clinic Patients

Redefining Alzheimer’s Disease: A Podcast with Heather Whitson, Jason Karlawish, Lon Schneider

GeriPal

DECEMBER 1, 2023

In particular we spend a good deal of time talking about what this means for asymptomatic patients who may have an abnormal biomarker, which by the proposed new definition would mean they would now have Alzheimer’s disease. Eric: Wonderful. Jason: A bit of an irony there is that Simple Minds is the band. laughter] Heather: Good point.

IT Clinic Illness Hypertension

Primary Care Digest

FDA’s New RWE Guidance Provides Recommendations for Sponsors Conducting Non-Interventional Real-World Studies and Describes the Potential to Use RWE for Initial Approvals in One Limited Circumstance

Redefining Alzheimer’s Disease: A Podcast with Heather Whitson, Jason Karlawish, Lon Schneider

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