The U.S. Food and Drug Administration today cleared the first test for Staphylococcus aureus (S.aureus) infections that is able to quickly identify whether the bacteria are methicillin resistant (MRSA) or methicillin susceptible (MSSA).
Category Archives: Drug Recalls & Safety Notices
FDA approves new treatment for rare type of pancreatic cancer
On Thursday, the U.S. Food and Drug Administration approved Afinitor (everolimus) to treat patients with progressive neuroendocrine tumors located in the pancreas (PNET) that cannot be removed by surgery or that have spread to other parts of the body (metastatic).
FDA issues final guidance for liquid OTC drug products with dispensing devices
The U.S. Food and Drug Administration today released its final guidance to firms that manufacture, market, or distribute over-the-counter (OTC) liquid drug products.
FDA issues first new rules under Food Safety Modernization Act
The U.S. Food and Drug Administration today announced two new regulations that will help ensure the safety and security of foods in the United States. The rules are the first to be issued by the FDA under the new authorities granted the agency by the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January. Both rules will take effect July 3, 2011.
FDA, FTC act to remove fraudulent STD products from the market
The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) today announced a joint effort to remove products from the market
FDA approves new treatment for Type 2 diabetes
The U.S. Food and Drug Administration today approved Tradjenta (linagliptin) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.
FDA looks to improve design and cleaning instructions for reusable medical devices
The U.S. Food and Drug Administration today announced steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to the transmission of disease.
FDA requests seizure of adulterated breaded seafood at Wisconsin firms
Yesterday, at the request of the U.S. Food and Drug Administration, U.S. Marshals seized breaded seafood products that have been repacked by Fellerson, Inc., a firm that does business as K&S Wholesale Meats, for Soderholm Wholesale Foods, both of Sun Prairie, Wis., because the products are adulterated.
FDA approves Zytiga for late-stage prostate cancer
The U.S. Food and Drug Administration today approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).
FDA seeks permanent injunction against Pennsylvania dairy
The Justice Department, at the request of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Daniel L. Allgyer, owner of the Rainbow Acres Farm, in Kinzers, Pa., for distributing unpasteurized (or “raw”) milk for human consumption in interstate commerce.