As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily

Quick Notes Today’s Quick Notes include a drug shortages survey conducted by the American Society of Health-System Pharmacists, an AARP analysis of drug price increases and a request for comments…

Extended timelines alone are not sufficient to achieve transition to the new European medical device regulations, Team NB — the European Association of Medical devices Notified Bodies — says in…

New resources are needed to support CMS’s Coverage and Analysis Group’s coverage decisions for FDA-approved breakthrough medical devices, says a new report from AdvaMed and Health Management Associates, to decrease…

The complex process of regulating combination products begins with the FDA’s determination of which center — CDRH, CBER or CDER — will take the lead role in overseeing a product’s…

Datascope/Maquet/Getinge’s Cardiosave Hybrid and Rescue Intra-aortic Balloon Pump (IABP) is seeing a recall deemed class I — the most serious type of recall as use of the device may cause…

A federal appeals court handed another win to Axonics in its ongoing battle with Medtronic over claims that Medtronic’s patents for a sacral-nerve stimulation device are invalid. Source: Drug Industry…

Two draft guidances with the FDA’s recommendations for Biosimilar User Fee Act (BsUFA III) classification categories and preparation for formal meetings with agency staff were issued today. Source: Drug Industry…

Acknowledging that collecting diverse patient data prior to drug approval is not always feasible, the FDA has published draft guidance that gives direction on gathering underrepresented population data in the…

Two large pharmaceuticals announced acquisitions designed to bolster their portfolios in biotechnology with Novo Nordisk — maker of Wegovy — acquiring Inversago Pharma, also working on a weight loss drug;…