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All people are not the same. While glaringly obvious, that truth is often ignored in clinical trials. And fixing that problem requires companies to understand and overcome a myriad of barriers, according to a panel discussion held at the annual meeting of the Regulatory Affairs Professionals Society (RAPS) in Phoenix this week. Read More
CAREstream Medical drew an FDA Form 483 citing various failures in documentation following an agency inspection of the company’s Maitland, Fla., facility from April 25-27. Read More
South Korea’s Lunit INSIGHT CXR artificial intelligence (AI) system improved radiologists’ findings in chest X-rays in four abnormalities, according to study findings published in JAMA Network Open on Aug. 31. Read More
Planning for a drug or device recall, training for it and executing it with a heaping helping of humility are the key steps to managing a recall without sinking your business, according to Matt Walker, director of business development for the risk management company Sedgwick. Read More
Manufacturers ready to establish a risk-based framework for computer software assurance throughout the software’s lifecycle now have a clearer place to start. Read More