The U.S. Food and Drug Administration is requesting input from stakeholders and the public relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications.
Category Archives: Drug Safety Information Podcasts
Consumers warned to avoid eating oysters from area 1642 in Apalachicola Bay, Florida
The U.S. Food and Drug Administration is advising consumers, restaurant operators, commercial shippers and processors of shellfish not to eat, serve, purchase, sell or ship oysters from Area 1642 in Apalachicola Bay, Fla. because the oysters may be contaminated with toxigenic Vibrio cholerae serogroup O75.
FDA expands approved use for carotid stent
The U.S. Food and Drug Administration today approved an expanded indication that will allow a new group of patients at risk of stroke due to clogged neck arteries to be treated with the RX Acculink carotid stent.
FDA clears first test to quickly diagnose and distinguish MRSA and MSSA
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).
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.