Category: Food & Drug Administration (FDA)
Baxter International recalls 2 lots of its peritoneal dialysis solution after finding potential contamination during the manufacturing process.
Baxter (NYSE:BAX) is pulling back 2 lots of its peritoneal dialysis solution over concerns that the product may have been contaminated during the manufacturing process.
The FDA puts its highest-risk label on a recall of Enhancement Medical's Expression intranasal gel after the company gets nearly 70 complaints.
Enhancement Medical got the FDA's highest-risk recall warning over manufacturing concerns about the company's Expression Intranasal Splint.
The FDA proposes guidance for its de novo medical device review pathways and finalized its advice for small companies who must comply by the new Unique Device Identifier rules.
The FDA issued a pair of new documents this week outlining the agency's thinking on review of breakthrough medical devices and providing guidance for small companies trying to keep up with the new Unique Device Identifier program.
In a draft guidance proposed today the FDA offered some advice for companies developing novel devices that they believe are low-risk and thus eligible for more lenient review.
Sweden-based XVIVO Perfusion lands FDA Humanitarian Use Device approval for its flagship XPS system for preserving donor lungs.
The FDA granted Humanitarian Use Device approval for Sweden-based XVIVO Perfusion for its XPS tissue transport system for preserving donor lungs.