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The FDA’s draft guidances for OTC and prescription point-of-care blood glucose tests create overly burdensome clinical trial requirements that may chill development of new products, stakeholders say. Read More
Devicemakers preparing for an FDA inspection should take steps to avoid some of the most common mistakes, such as lapses in complaint-handling procedures, David Lim, president and CEO of www.RegulatoryDoctor.com, said during a recent FDAnews webinar. Read More
Wright Medical’s Augment Bone Graft is once more on the road to FDA approval, following the agency’s agreement to accept a further PMA amendment on the product. Read More
The EU Parliament Wednesday advanced major data privacy legislation, but made revisions to the proposal that removed two provisions that industry had said would cripple clinical research efforts. Read More
Just as Hospira’s Rocky Mount, N.C., production plant was starting to reel itself back from a devastating 2010 FDA inspection, the facility has been handed a fresh warning letter complaining that its corrective and preventive action procedures fall short of expectations. Read More
Northwestern University may have withheld information during a Senate probe on the use of an unapproved heart device, a key lawmaker claims in a new letter to the university and its hospital. Read More
Boston Scientific’s Rebel Platinum Chromium Coronary Stent System has gained CE Mark approval for patients with coronary artery disease, the devicemaker said Wednesday. Read More
Philips Respironics has initiated a voluntary worldwide recall of about 600 Trilogy ventilators due to a potentially defective component on the power management board. Read More
Four patients died after switching to a new form of controller for Thoratec’s HeartMate II Left Ventricular Assist System, the company revealed in a Tuesday recall announcement, adding the deaths did not involve a product malfunction. Read More