FDA Issues Safety Alert for Bioprosthetic Aortic Valves Because of Reduced Leaflet Motion
In a safety alert issued on October 5, the Food and Drug Administration (FDA) noted recent reports of reduced leaflet motion in some bioprosthetic aortic valves, including both SAVR (surgical aortic valve replacement) and TAVR (transaortic valve replacement) devices. Most cases of reduced leaflet motion were discovered by advanced … [Read more...] about FDA Issues Safety Alert for Bioprosthetic Aortic Valves Because of Reduced Leaflet Motion
Marketing Practices of Pharmacia Deemed Improper
FDA Warns About Fake Botox. The U.S. Food and Drug Administration (FDA) is warning consumers to be aware of fake botox. In a safety notification posted on the agency's website on April 16th, the FDA said a counterfeit version of Botox was identified in the United States. The bogus products may have been sold to doctors' … [Read more...] about Marketing Practices of Pharmacia Deemed Improper
FDA Reviews Safety Notification Procedures
FDA Review Safety Notification Procedures. The U.S. Food and Drug Administration (FDA) is looking at how it tells the public about safety concerns with foods, prescription drugs, medical devices, and other products it regulates, the agency's commissioner said on Thursday. "How we communicate what we do is as important as … [Read more...] about FDA Reviews Safety Notification Procedures
