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 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).
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 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.
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.
Navitas Naturals Issues Voluntary Recall for Organic Sprouted Chia Seed Powder Products
Navitas Naturals, the Superfood Company is voluntarily recalling products which contain Organic Sprouted Chia Powder due to possible health risks related to Salmonella contamination. “We have chosen to voluntarily recall products containing Organic Sprouted Chia Powder with the goal of utmost safety for our consumers� stated Zach Adelman, Navitas Naturals CEO.
Eugene Oregon, Inc. Issues Voluntary Nationwide Expansion Of The Recall Of All Lots Of African Black Ant, Black Ant, And Mojo Risen Dietary Supplements Which May Contain Undeclared Active Pharmaceutical Ingredients
Eugene Oregon, Inc. of Levittown, Pennsylvania is voluntarily expanding the recall of the
following products to the consumer level. This recall is a revised version of the recall issued on May 5, 2014 and is revised to reflect
the recall of ALL LOTS of the recalled products
American Importing Co, Inc Issues Allergy Alert On Undeclared Almonds Mispacked As Cinnamon Crunch Granola
American Importing Co, Inc of Minneapolis, MN is voluntarily recalling a limited number of packages of a single lot of Cinnamon Crunch Granola because they may contain undeclared almonds. People who have an allergy or sensitivity to almonds run the risk of serious or lifethreatening allergic reaction if they consume this product.
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Pet Center, Inc. Voluntary Recall of 3 oz bag of Lamb Crunchy’s Because of Possible Health Risk
Pet Center, Inc of Los Angeles, CA. is voluntarily recalling its 3 oz bag of Lamb Crunchy’s dog treats (LAM-003) (UPC# 727348200038) with date code 122015 product of USA, because it has the potential to be contaminated with Salmonella.
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