FDA Law
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.
My Green Doctor
MAY 3, 2025
In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Powering Health, Protecting the Planet – Why Renewable Energy Belongs in Every Clinic Healthcare professionals have always been trusted voices on public health.
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FDA Law
AUGUST 4, 2022
Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. After all, Lilly offered access to treatment for critically ill patients in financial need who would otherwise have to forego treatment or be saddled with a $13,000 per year copay. Background.
The Medical Futurist
JUNE 21, 2025
Treating less serious ailments gets faster, more targeted and more efficient, while the means for curing more serious and life-altering illnesses improve. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. Here, I outlined the way technology delineates the future of eye care and vision.
FDA Law
OCTOBER 25, 2021
The regulatory uncertainty has ill?befitted In the PMA context, the statute permits FDA to withhold approval if manufacturing facilities do not conform to QSR requirements. FDA says inspections may be necessary if a device has “critical and/or novel manufacturing processes that may impact the safety and effectiveness of the device.”
GeriPal
MAY 5, 2022
Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? We talk with Nick and Meg about: Why hearing loss is important not just in geriatrics but also for those caring for seriously ill individuals. I’m guessing not. How to screen for hearing loss. Transcript.
CDOCS
APRIL 14, 2021
& But, I don’t know if anything has done as much for bringing CAD/CAM into general dentistry offices more than the ability to manufacture zirconia restorations chairside.</span></p> & But, more importantly to me clinically, was the improvement in radiopacity.&
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