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Republican lawmakers are renewing their push to speed FDA approvals by allowing the agency to automatically approve drugs and devices that have been approved and sold in other developed and trustworthy countries. Read More
The Ironworkers District Council of New England Health and Welfare Fund has filed a class action complaint against Teva Pharmaceuticals accusing the company of a nearly decade-long anticompetitive scheme to delay generic competition for its QVAR (beclomethasone dipropionate HFA) asthma inhalers. Read More
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
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
Philips Respironics reports risk assessments of its continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) sleep apnea therapy devices showed that degraded sound abatement foam on the devices would likely not cause “appreciable harm” to patient health. Read More
Among devices subject to an FDA Class I recall from 2018-2022, only one-quarter of recall notices included adequate information to accurately identify the device or component at fault, according to a new study. Read More