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).
Category Archives: Drug Safety Information Podcasts
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.
FDA approves Dalvance to treat skin infections
The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.
FDA targets illegal online pharmacies in globally coordinated action
The U.S. Food and Drug Administration, in partnership with other federal and international agencies, took action this week against websites that sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The FDA and the U.S. Customs and Border Protection (CBP) also conducted extensive examinations at U.S.-based international mail facilities, where many packages containing prescription drugs enter the U.S., and found that most of the examined packages contained illegal prescription drugs that had been ordered from online sources.
FDA approves first molecular (gene-based) test to determine red blood cell types in transfusion medicine
The U.S. Food and Drug Administration today approved the Immucor PreciseType Human Erythrocyte Antigen (HEA) Molecular BeadChip Test – the first FDA-approved molecular assay used in transfusion medicine to assist in determining blood compatibility. The assay can be used to determine donor and patient non-ABO/non-RhD (non-ABO) red blood cell types in the United States.
FDA approves Entyvio to treat ulcerative colitis and Crohn’s disease
The U.S. Food and Drug Administration today approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn’s disease.
U.S. Marshals seize unapproved drugs from Ohio distributor
U.S. Marshals, at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Ohio, have seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories of Montvale, N.J. and distributed by Masters Pharmaceuticals, Inc. of Cincinnati, Ohio.
FDA requiring lower starting dose for sleep drug Lunesta
The U.S. Food and Drug Administration today announced it required the manufacturer of the sleep drug Lunesta (eszopiclone) to change the drug label and lower the current recommended starting dose. Data show that eszopiclone levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving, even if they feel fully awake.
FDA allows marketing of first prosthetic arm that translates signals from person’s muscles to perform complex tasks
The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrodes.