Today the U.S. Food and Drug Administration authorized for marketing the Affymetrix CytoScan Dx Assay, which can detect chromosomal variations that may be responsible for a child’s developmental delay or intellectual disability. Based on a blood sample, the test can analyze the entire genome at one time and detect large and small chromosomal changes.
Category Archives: Drug Safety Information Podcasts
FDA Commissioner Margaret A. Hamburg’s Statement on the 50th Anniversary Surgeon General’s Report on Smoking and Health
The 50th anniversary of the release of the Surgeon General’s Report on Smoking and Health is an opportunity to reflect on the important progress that has been made in tobacco control and to look ahead on addressing this critical public health issue. In 2014, tobacco remains the leading preventable cause of disease and death in this country. For five decades, the Department of Human Health and Services has played a critical role in developing and implementing proven comprehensive tobacco control programs and policies aimed at preventing tobacco use, especially among youth, and encouraging cessation. The Surgeon General’s Report provides a scientific foundation for public health action to reduce the public health impact of tobacco use.
FDA approves Mekinist in combination with Tafinlar for advanced melanoma
This week the U.S. Food and Drug Administration approved Mekinist (trametinib) in combination with Tafinlar (dabrafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (late-stage).
FDA approves first gel for sealing corneal incision after cataract surgery
The U.S. Food and Drug Administration today approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults. Prior to today’s approval, stitches were the only option for closing a leaking corneal incision after cataract surgery.
FDA approves Farxiga to treat type 2 diabetes
The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
FDA approves Tretten to treat rare genetic clotting disorder
The U.S. Food and Drug Administration today approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency.
FDA warns consumers not to use muscle growth product
The U.S. Food and Drug Administration is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.
FDA announces voluntary nationwide recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy
The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and Dec. 17, 2013.
FDA proposes new food defense rule
As required by the bipartisan Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration today proposed a rule that would require the largest food businesses in the United States and abroad to take steps to prevent facilities from being the target of intentional attempts to contaminate the food supply.
Montana dietary supplement maker found in contempt of court
The U.S. Food and Drug Administration announced today that on Dec. 4, 2013, a Livingston, Mont., dietary supplement maker was found in civil contempt of court for repeatedly violating the terms of a consent decree of permanent injunction that resolved a 2010 civil case against the company and its owner.