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…

This edition of Quick Notes looks at recent FDA medical device clearances and designations for EndoSound, EndoQuest Robotics, Perfuze, AnX Robotics, CGBio. Source: Drug Industry Daily

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). Source: Drug Industry Daily

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.…

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,…

This edition of Quick Notes looks at recent M&As involving Bristol Myers Squibb, Novartis and Roche. Source: Drug Industry Daily

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. Source: Drug Industry…

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…

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. Source: Drug Industry…

To regulate new medical device technologies, the FDA should rely on familiar regulatory processes to review low-risk activities while adopting a more attentive approach that devotes greater resources to high-risk…