The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Category Archives: Drug Safety Information Podcasts
FDA approves Perjeta for neoadjuvant breast cancer treatment
The U.S. Food and Drug Administration today granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer.
FDA awards seven grants to stimulate development of pediatric medical devices
The U.S. Food and Drug Administration today announced it has awarded seven grants totaling more than $3.5 million to various pediatric device consortia to boost the development and availability of medical devices for children.
FDA issues final guidance on mobile medical apps
Today, the U.S. Food and Drug Administration issued final guidance for developers of mobile medical applications, or apps, which are software programs that run on mobile communication devices and perform the same functions as traditional medical devices. The guidance outlines the FDA’s tailored approach to mobile apps.
FDA approval expands access to artificial heart valve for inoperable patients
The U.S. Food and Drug Administration today approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of the heart valves that causes narrowing of the aortic valve, restricting blood flow from the heart.
U.S. Marshals seize food products at two Virginia food companies
U.S. Marshals seized food products at Gourmet Provisions, LLC and Royal Cup, Inc., after U.S. Food and Drug Administration investigators found widespread and active rodent and insect infestation on the premises.
FDA finalizes new system to identify medical devices
Today, the U.S. Food and Drug Administration announced a final rule for the unique device identification system (UDI) that, once implemented, will provide a consistent way to identify medical devices.
FDA and NIH create first-of-kind Tobacco Centers of Regulatory Science
The U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH) today, as part of an on-going interagency partnership, have awarded a total of up to $53 million to fund tobacco-related research in fiscal year 2013 to create 14 Tobacco Centers of Regulatory Science (TCORS).
Federal judge approves consent decree against Shamrock Medical Solutions Group
The U.S. Food and Drug Administration announced today that federal judge Algenon L. Marbley of the Southern District of Ohio has approved a consent decree of permanent injunction against Shamrock Medical Solutions Group, LLC, of Lewis Center, Ohio, and four of its corporate officers and employees for continued drug manufacturing and labeling violations that resulted in the distribution of mislabeled drugs.
FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert
The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices (CGMP).