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…
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…
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…
An FDA advisory committee turned down Intercept Pharmaceuticals’ push for an Accelerated Approval for its fatty liver drug Ocaliva (obeticholic acid) by a 15-1 vote, but did leave the door…
Center for Biologics Evaluation and Research (CBER) Director Peter Marks and Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni laid out their centers’ current priorities and how they’re…
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…
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…
Despite lingering concerns of a potential relationship to preterm birth (PTB), an FDA advisory committee supported Pfizer’s maternal respiratory syncytial virus vaccine Abrysvo (RSVpreF) to prevent severe RSV in infants…
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. Source: Drug Industry…
Marketing authorization holders, wholesalers, distributors and manufacturers should have a shortage prevention plan specific to their role and strengthen the reliability and resilience of their supply chains to help prevent…