The FDA has classified the most recent recall of certain Philips Trilogy ventilators as class I, the most serious type of recall as use of the device may lead to…

Incorporating off-the-shelf (OTS) software into medical devices is becoming more common but a new guidance from the FDA advises that when using prepared software from another manufacturer, devicemakers still bear…

Illumina received notice in July that the Securities and Exchange Commission (SEC) was conducting an investigation into the company’s acquisition of Grail, requesting documents from the company over the beleaguered…

Oncopeptides is appealing a formal request from the FDA to withdraw its blood cancer therapy drug Pepaxto (melphalan flufenamide) as the agency flexes its newfound regulatory authority for pulling drugs…

PhRMA, the National Infusion Center Association and the Global Colon Cancer Association have filed a motion for summary judgment — a final decision made by a judge without going to…

More than 60 percent of the drugs approved last year won their FDA nod on the basis of a single clinical trial that was conducted by the drug sponsor, a…

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…