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In an effort to stay dominant in the burgeoning obesity market and expand in the liver disease space, Novo Nordisk has forged two new research partnerships, each potentially worth up to $532 million. Read More
In a move that sidesteps pharmacy benefit managers, Eli Lilly has launched a direct-to-consumer marketing program that will provide several of the company’s medicines for obesity, migraine, and diabetes at steeply discounted prices, and without the need for a face-to-face doctor visit. Read More
The FDA has issued a warning to patients and health care providers to not use the Synovo Total Hip System including resurfacing implants, manufactured by Synovo Production after 2019, because components of the system have been modified from the cleared device and the safety and effectiveness has not been established. Read More
Encouraging the FDA to put in place rules that govern the use of AI in healthcare is the focus of a letter Rep. Greg Murphy (R-N.C.) has sent to FDA Commissioner Robert Califf, pointing to the need to clarify liability guidance and overlapping governance, both of which he says are undermining manufacturers. Read More
This edition of Quick Notes looks at recent FDA medical device clearances and designations for EndoSound, EndoQuest Robotics, Perfuze, AnX Robotics, CGBio. Read More
A New Jersey judge ruled last week that Teva Pharmaceuticals did not infringe on two Corcept patents for its Cushing’s syndrome drug Korlym (mifepristone). Read More
The FTC won its motion to temporarily block IQVIA’s planned purchase of California health advertising firm Propel Media, deeming further review by the commission would be in the public interest. Read More
CDRH is now issuing electronic export documents for medical devices instead of paper to improve efficiency, reduce the amount of time it takes for a manufacturer to receive export documents, and decrease environmental burden. Read More
In its continuing effort to step up post-pandemic enforcement activities, the FDA wrapped up 2023 by making public three Form 483s for as many Indian pharmaceutical manufacturers. Read More
The FDA is increasingly finding cybersecurity lapses during inspections of medical device manufacturing facilities — and most often because cybersecurity risk management is not fully documented as part of design controls, according to compliance expert Eric Henry. Read More
The FDA is seeking input from a wide variety of stakeholders on a draft report on best practices for streamlining the development, dissemination and use of guidances. Read More