Today, the U.S. Food and Drug Administration completed its evaluation for two varieties of apples genetically engineered by Okanagan Specialty Fruits, Inc., and for six varieties of potatoes genetically engineered by J. R. Simplot Company and concluded that these foods are as safe and nutritious as their conventional counterparts.
Category Archives: Drug Safety Information Podcasts
FDA approves Cholbam to treat rare bile acid synthesis disorders
Today the U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders). Patients with these rare, genetic, metabolic conditions exhibit manifestations of liver disease, steatorrhea (presence of fat in the stool) and complications from decreased fat-soluble vitamin absorption.
FDA releases final guidance on reprocessing of reusable medical devices
The U.S. Food and Drug Administration today announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses.
FDA releases final guidance on reprocessing of reusable medical devices
The U.S. Food and Drug Administration today announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses.
Federal judge enters consent decree against Specialty Compounding LLC
U.S. District Judge Lee Yeakel entered a consent decree of permanent injunction on March 10, 2015 between the United States and Specialty Compounding LLC, of Cedar Park, Texas, and the company’s co-owners, Raymond L. Solano, III and William L. Swail. According to the complaint filed with the consent decree, Specialty Compounding manufactured purportedly sterile injectable drug products that tested positive for bacterial contamination. The U.S. Department of Justice brought the action on behalf of the U.S. Food and Drug Administration.
FDA approves first therapy for high-risk neuroblastoma
The U.S. Food and Drug Administration today approved Unituxin (dinutuximab) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.
FDA approves CPR devices that may increase chance of surviving cardiac arrest
The U.S. Food and Drug Administration today approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may improve the patient’s chances of surviving cardiac arrest.
FDA approves CPR devices that may increase chance of surviving cardiac arrest
The U.S. Food and Drug Administration today approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may improve the patient’s chances of surviving cardiac arrest.
FDA approves new antifungal drug Cresemba
The U.S. Food and Drug Administration today approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections.
FDA authorizes use of first device to treat patients with dialysis-related amyloidosis
The U.S. Food and Drug Administration today authorized use of Lixelle Beta 2-microglobulin Apheresis Column, the first device to treat dialysis-related amyloidosis (DRA).