The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites. The committee discussed the bills with various experts and Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who offered no opposition to any of the measure...

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Asks to Suspend Authorizations of Four Imaging Agents After Reviewing Safety The Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents. PRAC put forward the proposal after finding “convincing evidence” accumulations of gadolinium are present in the brain many month...

The US Food and Drug Administration (FDA) has announced its intent to establish a new patient registry to assess the postmarketing risks of several contrast agents used in magnetic resonance imaging and angiography (MRI/MRA). In an 18 July posting in the Federal Register , FDA noted six of the eight gadolinium-based contrast agents (GBCAs) used in MRIs and MRAs are associated with nephrogenic systemic fibrosis (NSF)-a condition that causes excessive connective tissue ...