This document describes how to properly qualify and validate drug manufacturing processes, facilities, equipment, utilities and analytical methods. Guidance documents like this one are meant to help ...

Forward-thinking manufacturers build native compliance protocols as a workflow, not as an afterthought—a pitfall that many ...

Introduction Angina with no obstructive coronary artery disease (ANOCA) affects millions and is frequently under-recognised because diagnostic pathways and risk tools predominantly target obstructive ...

You have reached your maximum number of saved items. Remove items from your saved list to add more. The Trump administration’s portfolio of strategic technology companies has expanded across the ...

HOUSTON – (April 28, 2026) – Motif Neurotech, a company commercializing technology based on research at Rice University, has received approval from the U.S. Food and Drug Administration to begin the ...

Sibel Health, a medical technology company, has received FDA 510(k) clearance for ANNE Maternal, a wireless maternal-fetal monitoring platform that integrates wearable sensor technology with clinical ...

BOSTON--(BUSINESS WIRE)--Nia Therapeutics announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Smart Neurostimulation System (SNS) for the treatment ...

The Smart Neurostimulation System is the first neurostimulation device to receive Breakthrough designation for TBI-related memory loss; the implant decodes memory states from neural activity on 60 ...

Replacing animal testing with alternate methodologies in preclinical drug trials holds potential for the development of cheaper, safer pharmaceuticals as well as alleviating animal suffering. But ...

TechCrunch Disrupt Battlefield 2023 winner BioticsAI announced on Monday that it has received FDA clearance for its AI software that helps detect fetal abnormalities in ultrasound images. The product ...