Regulation

How Do Unapproved Drugs Make it to Market?

It may come as a surprise that some of the drugs your doctor can prescribe have not been approved by the Food and Drug Administration (FDA). That means that they haven’t been evaluated for safety or efficacy, and there isn’t …

FDA Approves the First Ever MRI-Safe Pacemaker

On Tuesday, the U.S. Food and Drug Administration approved the first pacemaker designed to be used safely during magnetic resonance imaging (MRI) scans. The device, the Revo MRI SureScan Pacing System by Medtronic, was first …

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