The Medical Futurist
JUNE 17, 2025
Artificial intelligence Already, dentists employ software to get insights into clinical decision-making, but AI is changing the face of dentistry, just like it is in many other fields. But AR also found a home in dentistry for both educational and clinical purposes.
FDA Law Blog
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. products intended for medical purposes).
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The Medical Futurist
JUNE 21, 2025
In 2016, The Guardian reported that a blind woman suffering from this disease was fitted with the implant labelled “bionic eye” in the UK as part of a trial at the Oxford Eye Hospital. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. The drug helped decrease the initial healing from 5 days.
FDA Law Blog
JANUARY 15, 2024
FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.
FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
FDA Law Blog
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” This discussion paper is not the first time that FDA has grappled with the tricky regulatory questions presented by 3D printing. products intended for medical purposes).
FDA Law Blog
SEPTEMBER 6, 2022
This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. The Draft Guidance covers charging in a clinical trial or in one of the expanded access settings and the differences between them. What’s new in the new Draft Guidance?
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