FDA publishes a guidance with general information on the electronic submission of specified postmarketing safety reports to CBER and CDER.
FDA says it is evaluating reports of an increased risk of airway obstruction associated with two Medtronic silicone-based EMG endotracheal tubes.
Federal Register notice: FDA seeks industry organizations interested in participating in selecting a nonvoting industry representative to serve on the...
CDRH chief digital health officer of global strategy and innovation Bakul Patel explains the work he will be addressing in his new position.
FDA warns Brea, CA-based Clinical Resources Laboratory about CGMP violations in its production of misbranded unapproved new drugs.
Attorney Bryan Feldhaus says the revised FDA intended use regulation clarifies but does not change the definition of intended use and should not adver...
FDA warns San Diego, CA-based Vitae Enim Vitae Scientific about repeat CGMP violations in its work producing finished drugs as a contract manufacturer...
The House Select Subcommittee on the Coronavirus Crisis is asking for an FDA briefing on the status of vaccination for children under age 5 and whethe...