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Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from advanced gene and cell therapy, ICH E8 R1 recommendations and FDA’s sterilization pilot. Read More
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
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. 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