The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).
FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors
The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).
FDA takes action against Kansas food manufacturer for repeated food safety violations
The U.S. District Court for the District of Kansas entered a consent decree of permanent injunction today between the United States and Native American Enterprises, LLC, located in Wichita, Kansas; its part-owner, William N. McGreevy; and its production manager, Robert C. Conner.
FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC).
FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer
The U.S. Food and Drug Administration today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor (EGFR) gene mutations in non-small cell lung cancer patients. Such mutations are present in approximately 10-20 percent of non-small cell lung cancers (NSCLC).
FDA issues draft guidance to food industry for voluntarily reducing sodium in processed and commercially prepared food
Today, the U.S. Food and Drug Administration issued draft guidance for public comment that provides practical, voluntary sodium reduction targets for the food industry. Average sodium intake in the U.S. is approximately 3,400 mg/day. The draft short-term (two-year) and long-term (10-year) voluntary targets for industry are intended to help the American public gradually reduce sodium intake to 2,300 milligrams (mg) per day, a level recommended by leading experts and the overwhelming body of scientific evidence. The targets are also intended to complement many existing efforts by food manufacturers, restaurants, and food service operations to reduce sodium in foods.
Kashi Company Voluntarily Recalls One Variety of Kashi® Granola Bars and One Variety of Bear Naked® Granola Due to Potential Health Risk Related to Sunflower Seeds
Kashi Company today announced a voluntary recall of Kashi® Trail Mix Chewy Granola Bars and Bear Naked® Soft Baked Granola, Cinnamon + Sunflower Butter in the continental United States because they contain ingredients made from sunflower seeds distributed by our supplier, SunOpta, that have the potential to be contaminated with Listeria monocytogenes.
Kashi Company Voluntarily Recalls One Variety of Kashi® Granola Bars and One Variety of Bear Naked® Granola Due to Potential Health Risk Related to Sunflower Seeds
Kashi Company today announced a voluntary recall of Kashi® Trail Mix Chewy Granola Bars and Bear Naked® Soft Baked Granola, Cinnamon + Sunflower Butter in the continental United States because they contain ingredients made from sunflower seeds distributed by our supplier, SunOpta, that have the potential to be contaminated with Listeria monocytogenes.
Expanded Voluntary Recall on Certain Backroad Country Brand Sunflower Kernel Products
Troyer® Cheese Inc, under advice from its packaging facility concerning, CRANBERRY NUT DELIGHT MIX PREPACK, HONEY ISLAND CRUNCH MIX PREPACKAGED, PRETZELS PEANUT BUTTER PREPACKAGED, WALNUT HALVES/PIECES PREPACKAGED, SUNFLOWER SEEDS R&S PREPACKAGED AND SUNFLOWER SEEDS R&S BULK is recalling a limited number of products that have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
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Gold Medal, Gold Medal Wondra, and Signature Kitchens Flour Recalled Due to Possible E. coli O121 Contamination
General Mills is collaborating with health officials to investigate an ongoing, multistate outbreak of E. coli O121 that may be potentially linked to Gold Medal flour, Wondra flour, and Signature Kitchens flour (sold in Safeway, Albertsons, Jewel, Shaws, Vons, United, Randalls, and Acme). Out of an abundance of caution, a voluntary recall is being made.