CDER cites Teva Neuroscience for a clozapine sales detailer that is allegedly misleading because it makes unsubstantiated superiority claims, omits material facts, and minimizes the drug’s risks.
An FDA safety alert warns healthcare providers about the potential for damaged medical bed mattress covers to allow blood and body fluids to penetrate the mattresses.
FDA rebuts an “inaccurate and alarmist” 4/15 report by the Environmental Working Group that said superbugs with foodborne antibiotic resistance have invaded meat found in supermarkets.
GE Healthcare begins a field corrective action involving its Giraffe Incubator with a Servo Control Oxygen System and Giraffe OmniBed due to settings being reset after an interruption in power.
FDA approves an Alcon NDA for Simbrinza suspension, a combination drug indicated for reducing elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
FDA issues a new draft guidance to assist the device industry in preparing submissions for devices that come into direct or indirect contact with the human body in order to determine their potential toxicity.
Federal Register Notice: The Office of Management and Budget approves a collection of information on a health care professional survey of prescription drug promotion.
Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on medical device user fee small business qualification.
FDA clears a MedShape 510(k) for its Eclipse Soft Tissue Anchor, a shape memory fixation device designed to attach a tendon, ligament or soft tissue to bone.