Drug Industry Daily

The U.S. Justice Department (DOJ) has provided errant manufacturers with a way to avoid prosecution if they confess their misconduct right away. Source: Drug Industry Daily

After analyzing four additional years of data, the FDA has decided to reverse its 2019 judgment of the mortality risk of paclitaxel-coated devices, saying data do not support a finding of excess mortality risk. Source: Drug Industry Daily

The FDA’s recent final guidance on clinical decision support software prevents physicians from fully disclosing critical health information and therefore violates the First Amendment, a Florida law professor has written in her citizen petition to the FDA. Source: Drug Industry Daily

The European Medicines Agency (EMA) is conducting a safety review of GLP-1 receptor agonists such as Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) following 150 reports from the Icelandic Medicines Agency of suicidal thoughts and self-injury in people using one of the drugs for weight loss or type 2 diabetes. Source: Drug Industry Daily

Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the WCG MAGI Clinical Research Conference and a FDAnews webinar on design control. Source: Drug Industry Daily

Outset Medical has announced that it received a warning letter from the FDA for promoting use of its Tablo hemodialysis system for continuous renal replacement therapy (CRRT) which is outside of current indications for the device, and for a lack of clearance of TabloCart, an accessory for the system. Source: Drug Industry Daily

Dubbing the Patent Trial Appeal Board’s (PTAB) rationale “doubly infected by error,” the U.S. Federal Court of Appeals gave Axonics the win as it vacated PTAB’s denial of Axonics appeal against Medtronic and remanded the case back to PTAB for reconsideration. Source: Drug Industry Daily

Megadyne, an Ethicon company, is recalling its Mega 2000 and Megasoft reusable patient return electrodes — now deemed an FDA class I recall, the most serious type of recall as use of the device could lead to serious injury or death — after receiving reports of burn injuries as serious as third degree. Source: Drug…

EMA has issued revised guidance for its PRIority MEdicines (PRIME) scheme that provides early consultation and scientific advice between applicants and regulators for medicines under development and not currently authorized in the EU. Source: Drug Industry Daily

Optimizing dietary management during drug trials is critical to accurately assessing drug efficacy in clinical trials for inborn errors of metabolism (IEM), the FDA says in a new draft guidance. Source: Drug Industry Daily