Regulatory Affairs Professionals Society

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US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and NIH Director Francis Collins testified on Thursday before the House Energy & Commerce Committee on how their agencies have worked to implement provisions from the 21st Century Cures Act passed and signed by President Barack Obama a month before he left office. The hearing...

The US Food and Drug Administration (FDA) on Monday finalized guidance aimed at reducing the amount of radiation children are exposed to from x-ray imaging devices. While x-ray imaging can increase the risk of cancer for both adult and pediatric patients, FDA says that radiation is a greater concern for pediatric patients as they are more sensitive...

The Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team (DHS ICS-CERT) on Thursday issued an advisory detailing eight cybersecurity vulnerabilities found in Smiths Medical's Medfusion 4000 wireless infusion pumps. The vulnerabilities, identified by cybersecurity researcher Scott Gayou, range in severity from...

The US Food and Drug Administration (FDA) on Tuesday finalized guidance outlining recommendations on how medical devices should be able to securely interact with other devices and information systems. The guidance, first drafted in January 2016, is meant to assist manufacturers and FDA staff in identifying considerations related to the ability of...

A team of researchers from Novartis, Oracle Health Sciences and the University of California, San Francisco say the US Food and Drug Administration's (FDA) adverse drug reaction database could be improved by grouping drugs by their chemical structure and automating certain reporting functions. In a paper appearing in eLife earlier this month, the...