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Devicemakers have a better shot at emerging from an FDA inspection unscathed if they watch for common investigator tactics, such as stepping away from the company contact, an expert says. Read More
More devicemakers are choosing the de novo approval pathway to get novel low-risk technologies to market quickly, thanks to changes in the way the FDA reviews these products that took effect two years ago. But knowing how to pitch a petition is key to success, an expert says. Read More
Danaher’s plan to snap up dental implant company Nobel BioCare and Roche’s purchase of InterMune helped drive a strong third quarter for life sciences mergers and acquisitions, a new report from PricewaterhouseCoopers shows. Read More
Devicemakers may need to redesign scores of products and change their sterilization methods if the Environmental Protection agency goes through with plans to classify ethylene oxide as carcinogenic when inhaled by humans. Read More
The FDA is ordering manufacturers of power morcellators to add a black box warning to the devices and telling consumers the products are unsafe in almost all instances. Read More
The FDA slapped Mani Hanoi, a Vietnam maker of surgical sutures with attached needles, with a warning letter for particle monitoring slips and other GMP issues. Read More