FDA warns Berkeley, CA-based Libby Laboratories about CGMP violations in its manufacturing of finished drugs.
University of Illinois law school scholar Sara Gerke calls for FDA to create AI Facts labeling for artificial intelligence-powered medical devices.
A Foundation for Defense of Democracies paper calls on FDA to correct a gap in a recent guidance that makes in-use medical devices vulnerable to cyber...
FDA warns Clarksville, TN-based Insightra Medical about multiple violations in its production of intra-aortic balloon pump catheter kits with specific...
A new FDA clinical trial finds that cannabidiol may cause liver enzyme elevations in otherwise healthy adults raising new concerns about the safety o...
FDA approves an expanded indication for Insightecs Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients livin...
A letter from dozens of biotechnology industry executives and investors urges FDA commissioner Marty Makary to reject efforts to restrict access to th...
FDA drops REMS requirements covering embryofetal toxicity risk in endothelin receptor antagonists.
