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The FDA slapped Centaur Pharmaceuticals with a 10-observation Form 483 after investigators observed destruction of good manufacturing practice (GMP) documents, among other serious lapses. Read More
The Federal Trade Commission (FTC) is ramping up its oversight of health data collected electronically and plans to issue a new rule on notifications of health breaches to clarify the existing rule’s applicability to health apps and other similar technologies. Read More
A U.S. district judge in Minnesota has issued a judgment against Precision Lens and its owner, Paul Ehlen, to pay $487 million after a civil jury found them guilty of offering kickbacks to doctors performing Medicare-reimbursable surgeries. Read More
One-third of the healthcare-related suits brought by the Department of Justice (DOJ) in 2022 concerned medical device manufacturers, pharmaceutical wholesalers and retailers, focusing particularly on violations of anti-kickback and Stark Law violations and including individuals as well as companies. Read More
The FDA has cleared several impactful devices this week — one that can predict a dangerous pregnancy complication, one that measures heart arrhythmias for up to six years after insertion just under the skin, and one that can detect the brain plaque associated with Alzheimer’s in under five minutes. Read More
A five-year study of patients with acute coronary syndrome (ACS) revealed no notable difference in long-term clinical outcomes between those treated with titanium-nitride-oxide (TiNO)-coated stents or everolimus drug eluting stents (EES), both of which are used to widen narrow or blocked coronary arteries. Read More
Over the past week, the FDA issued notices of draft guidances on pediatric research, a final decision on withdrawal of Makena and a determination on Catapres products. Read More
CDRH Director Jeffrey Shuren aims to reverse a historical trend and make the U.S. the top destination for novel medical device launches, improving the center’s efficiency along the way. Read More
Clinical trial sites venturing into the growing field of digital therapeutics (DTx) need the appropriate infrastructure — as well as tech know-how and adaptability — while sponsors need to be willing to offer training and support, iron out hurdles that come with remote components and simplify these trials whenever possible, a clinical research expert advises. Read More