The U.S. Food and Drug Administration today approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have Hemophilia A. Eloctate is the first Hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.
Category Archives: Food Safety News
GreenSmoothieGirl Issues Voluntary Recall for Organic Sprouted Chia Seed Powder Products Because of Possible Health Risk
GreenSmoothieGirl is voluntarily recalling two products which contain Organic Sprouted Chia Powder due to possible health risks related to Salmonella contamination.
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Baptista’s Bakery Inc. Issues Voluntary Recall for LiveGfree Rosemary and Olive Oil Multiseed Snack Crackers
Baptista’s Bakery, Inc. is voluntarily recalling 4,339 cases of LiveGfree Gluten Free Rosemary and Olive Oil Multiseed Crackers with a best if used by date of 11-24-14 because they contain a seasoning that is being recalled by Kerry Ingredients. Kerry Ingredients is recalling the seasoning due to possible health risks related to Salmonella contamination.
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Hill’s Pet Nutrition, Inc. Voluntarily Recalls 62 Bags of “Science Diet® Adult Small & Toy Breed™” Dry Dog Food in California, Hawaii and Nevada Because of Potential Health Risk
Hill’s Pet Nutrition, Inc. of Topeka, KS is voluntarily recalling 62 bags of Science Diet® Adult Small & Toy Breed™ dry dog food as they have the potential to be contaminated with Salmonella. The suspect product, part of a single production run, was distributed to 17 veterinary clinic and pet store customers in California, Hawaii and Nevada between April 24 and May 13, 2014.
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FDA launches openFDA to provide easy access to valuable FDA public data
Today, the U.S. Food and Drug Administration launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency.
FDA approves first generic versions of celecoxib
The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.
FDA to require warnings on sunlamp products
Today, the U.S. Food and Drug Administration issued a final order reclassifying sunlamp products and ultraviolet (UV) lamps intended for use in sunlamp products from low-risk (class I) to moderate-risk (class II) devices. The order also requires that sunlamp products carry a visible black-box warning on the device that explicitly states that the sunlamp product should not be used on persons under the age of 18 years. In addition, certain marketing materials for sunlamp products and UV lamps must include additional and specific warning statements and contraindications.
FDA allows marketing of first non-invasive test to help in identifying cause of certain kidney disease
Today, the U.S. Food and Drug Administration allowed marketing of the first test that can help determine if a specific type of kidney disease, called membranous glomerulonephritis (MGN), is due to the body’s rejection of its own kidney tissue (autoimmune) or if it is due to another cause (such an infection).
La FDA aprueba el primer dispositivo inalámbrico implantable para medir la presión arterial pulmonar a distancia en ciertos pacientes con insuficiencia cardiaca
La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de los Estados Unidos aprobó hoy el Sistema CardioMEMSHF, que mide la presión arterial pulmonar (AP) y la frecuencia cardiaca de los pacientes con insuficiencia de la clase III, según la clasificación de la Asociación del Corazón de Nueva York (NYHA, por sus siglas en inglés), y que han sido hospitalizados por insuficiencia cardiaca en el último año. El dispositivo permite a los profesionales de la salud vigilar el estado de sus pacientes a distancia.
FDA approves first implantable wireless device with remote monitoring to measure pulmonary artery pressure in certain heart failure patients
The U.S. Food and Drug Administration today approved the CardioMEMSHF System that measures the pulmonary artery (PA) pressures and heart rates of patients with New York Heart Association (NYHA) Class III heart failure who have been hospitalized for heart failure in the previous year. The device allows health care professionals to monitor the condition of their patients remotely.