Category Archive: patient engagement

Jul 23 2019

Complicated Drug Product? FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient

By Dieanira Erudaitius, Ph.D, Scientist at Cato Research This month, July 2019, the United States Food and Drug Administration (FDA) released a new draft guidance to meet Prescription Drug User Fee Act (PDUFA) VI performance goals for patient‑oriented labeling. This draft guidance provides recommendations on the content and format development for Instructions for Use (IFU) …

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Mar 12 2019

Lets talk about Patient Engagement

patient engagement , clinical trials

Why does everyone talk about “Patient Engagement” in clinical trials? By Shirley Greenfeld Senior Clinical Research Associate As trials are becoming longer and more expensive and many of them fail to meet their recruitment goal, patient engagement plays a key role in the success of a clinical trial. But what is exactly patient engagement and …

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