In Brief: Chlorhexidine-impregnated devices
This article was originally published in The Gray Sheet
Executive Summary
Chlorhexidine-impregnated devices: FDA seeking feedback on potential for serious hypersensitivity reactions to products impregnated with the antimicrobial agent chlorhexidine as a result of reported adverse events in other countries. Agency's March 11 public health notice states that at least three device types incorporating the agent - intravenous catheters, topical antimicrobial skin dressings, and implanted antimicrobial surgical mesh - have been cleared by FDA...
You may also be interested in...
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.
Could Eledon’s Anti-CD40L Change Transplant Medicine?
Eledon Pharmaceuticals’ CD40 Ligand blocker has yielded impressive results for post-transplant immunosuppression and cutting-edge transplant doctors have also used it for pig-to-human kidney and heart transplants, opening up the field of xenotransplantation.