Today, the U.S. Food and Drug Administration published an interim final rule to further safeguard the health of infants fed infant formula in the United States. The rule, which sets standards for manufacturers to produce safe infant formula that supports healthy growth, is accompanied by two draft guidance documents for industry.
Today, the U.S. Food and Drug Administration announced that Commissioner Margaret A. Hamburg, M.D. will travel February 10-18 to India to further strengthen cooperation between the FDA and its Indian regulatory counterparts.
The U.S. Food and Drug Administration today announced the launch of a national public education campaign to prevent youth tobacco use and reduce the number of kids ages 12 to 17 who become regular smokers. ‘The Real Cost’ campaign is the FDA’s first of several planned tobacco education campaigns using the new authority granted under […]
The U.S. Food and Drug Administration today approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older.
The U.S. Food and Drug Administration today proposed a rule that would require certain shippers, receivers, and carriers who transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation.
The U.S. Food and Drug Administration today approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for […]
he U.S. Food and Drug Administration, in close coordination with the Wyoming Department of Agriculture (WDA) and the U.S. Department of Agriculture (USDA), has been working to address a tragic accident that occurred at the Western Sugar Cooperative’s Lovell, Wyo., manufacturing facility on Jan. 4, 2014.
The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.
The U.S. Food and Drug Administration today launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees.
• The U.S. Food and Drug Administration is warning consumers not to eat raw or partially cooked oysters harvested from Copano Bay, in Aransas County, Texas, harvested between Dec. 26, 2013 and Jan. 9, 2014.
The FDA thanks the Institute of Medicine (IOM) for convening the Aug. 5-6, 2013, public workshop on caffeine in food and dietary supplements. The FDA requested the workshop because we know how important it is to get the science right. The summary report that IOM issued today will be extremely informative as we continue our […]
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.
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 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).
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.
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.
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.
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.
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 […]