We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the WCG MAGI Clinical Research Conference and a webinar from FDAnews, a WCG company on design control. Read More
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. Read More
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. Read More
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. Read More
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. Read More
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to accurately assessing drug efficacy in clinical trials for inborn errors of metabolism (IEM), the FDA says in a new draft guidance. Read More
CMS has issued a proposed rule that aims to spend $9 billion to reimburse nearly 1,650 hospitals participating in the 340B drug discount program for underpayment of fees over the past five years. Read More
Coloplast has signed a $1.3 billion agreement to acquire Kerecis, a biologics wound care manufacturer based in Iceland, with an FDA-cleared patented technology platform based on intact fish skin. Read More
The FDA has classified Draeger Medical’s Oxylog 3000 Plus emergency and transport ventilator as class I, the most serious type of recall because of the risk of serious injury or death. Read More
Multiple U.S. government agencies, in collaboration with India’s Directorate of Revenue intelligence, have stopped over 500 shipments of “illicit, and potentially dangerous, unapproved prescription drugs, combination medical devices, and synthetic drug precursors from reaching American consumers.” 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
Novo Nordisk has sought legal action against 10 medical spas, weight loss and wellness clinics, and compounding pharmacies in four states for illegally selling non-FDA-approved compounded and counterfeit semaglutide products. Read More