Avioq HTLV-I/II Microelisa System, a test designed to detect antibodies to viruses in donors of human blood and blood components that are associated with several diseases, including some forms of leukemia and neurologic diseases, was approved today by the Food and Drug Administration.
Category Archives: Food Safety News
New FDA guidance on considerations used in device approval, de novo decisions
The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.
FDA approves Omontys to treat anemia in adult patients on dialysis
The U.S. Food and Drug Administration today approved Omontys (peginesatide) to treat anemia, a condition in which the body does not have enough healthy red blood cells, in adult dialysis patients who have chronic kidney disease (CKD).
El Ranchero Del Sur, LLC. Recall (Esta Piendo Devolución) Queso Fresco El Ranchero Del Sur, Queso Fresco En Hoja De Platano Los Corrales, Y Queso Hebra Queso Oaxaca El Ranchero Del Sur Debido A Posible Reigos De Salud
El Ranchero Del Sur, LLC. de South River, en el estado de Nueva Jersey está pediendo que devuelvan todos los productos Queso Fresco El Ranchero Del Sur de 14 onzas, Queso Fresco en Hoja de Plátano Los Corrales de 14 onzas, Queso Hebra Queso Oaxaca El Ranchero Del Sur de 14 onzas, y de 10 libras porque pueden estar potencialmente contaminados con Listeria monocytogenes, un organismo que puede causar graves y a veces infecciones mortales en niños pequeños, personas con estado de salud delicado, ancianos y personas con el sistema inmunológico débil. Aunque algunos individuos sanos pueden sufrir solo a corto plazo sÃntomas como fiebre alta, dolor de cabeza severo, rigidez, nauseas, dolor abdominal y diarrea, las infecciones de Listeria pueden causar abortos espontáneos y partos prematuros entre las mujeres embarazadas.
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FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease
The Food and Drug Administration today approved the LINX Reflux Management System for people diagnosed with gastroesophageal reflux disease (GERD) who continue to have chronic symptoms, despite the use of maximum medical therapy for the treatment of reflux.
FDA approves first Boniva generics to treat or prevent osteoporosis
The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.
FDA proposes lower risk classification for certain tuberculosis tests
The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis (TB). This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
FDA proposes lower risk classification, guidance for certain tuberculosis tests
The Food and Drug Administration issued a proposed rule today that would encourage the development of a type of test used to detect cases of tuberculosis. This rule would lower the current risk classification for nucleic acid-based tests allowing manufacturers to utilize the faster, more streamlined clearance pathway for medical devices.
FDA approves first generic Lexapro to treat depression and anxiety disorder
The U.S. Food and Drug Administration today approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.
Depression is characterized by symptoms that interfere with a person’s ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person’s lifetime.
La FDA aprueba nuevos implantes de seno rellenos de gel de silicona
La Administración de Alimentos y Drogas de los Estados Unidos (FDA) aprobó hoy los implantes de seno rellenos de gel de silicona fabricados por Sientra Inc. para aumentar el tamaño del seno (aumentación) en las mujeres por lo menos 22 años de edad y para reconstruir el tejido de los senos (reconstrucción) en las mujeres de cualquier edad.