Regulatory News In Brief
This article was originally published in The Gray Sheet
EV3 catheter recall: Firm recalls about 350 TrailBlazer support catheters Nov. 6 after receiving reports from physicians of cracking near the radiopaque marker band during the product's limited initial U.S. release. The malfunction could cause injuries such as insufficient oxygen supply to tissues, damage to blood vessels, heart attack or death, FDA said Jan. 5. The firm says the Class I recall was completed in December and all affected units have been returned to the company. A redesigned TrailBlazer support catheter was launched last month and is available worldwide, ev3 notes
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Companies may begin using new FDA device problem codes in their mandatory adverse event reports beginning July 1, the agency says. The new electronic Medical Device Reporting (eMDR) coding 1system revamps the previous system with specific improvements to patient and device problem codes, the inclusion of component codes to clarify the part of the device associated with the adverse event, and improvements to code descriptions and definitions, FDA says. Old MDR codes will still be accepted, but only until April 2, 2010 (2"The Gray Sheet" April 6, 2009)
Australia’s competition regulator, the ACCC, has granted a conditional dispensation to allow generics industry association the GBMA and brand body Medicines Australia to work together to help address the coronavirus pandemic by sharing information on stock, inventory, manufacturing and the supply chain. However, tender pricing will not be among the subjects discussed.
The UK biotech's CEO tells Scrip that Izana's objective is to treat rapidly deteriorating COVID-19 patients before ICU admission and prior to ventilation.