The U.S. Food and Drug Administration today approved Brintellix (vortioxetine) to treat adults with major depressive disorder.
Category Archives: Food Safety News
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.
Safeway Recalls Several Varieties of Angel Food Cake Due to Undeclared Soy and Milk Allergens
Safeway is voluntarily recalling six (6) Angel Food Cake products because they contain the undeclared allergens soy and milk. People who have an allergy or severe sensitivity to soy or milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
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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.
Semifreddi’s Announces Voluntary Recall of Almond Biscotti and Chocolate Dipped Almond Biscotti for Undeclared Milk and Soy
Semifreddi’s Inc. of Alameda, CA is recalling all packaged Almond Biscotti and Chocolate Dipped Almond Biscotti because the food allergens milk and soy were not declared on the product labels. People who have an allergy or severe sensitivity to milk or soy run the risk of serious allergic reaction, including anaphylaxis, if they consume the products.
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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).