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…

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…

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…

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…

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…

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…

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…

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…

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to accurately assessing drug efficacy in clinical trials for inborn errors of metabolism (IEM), the FDA says in a new draft guidance.…