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.
FDA warns Lenoir, NC-based Exela Pharma Sciences about CGMP violations in its work as a drug manufacturing outsourcing facility.
Forty health advocacy groups led by the Association for Accessible Medicines voice their support for legislation to eliminate the distinction between ...
