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.
Category Archives: Drug Safety Information Podcasts
FDA launches its first national public education campaign to prevent, reduce youth tobacco use
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 Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009.
FDA approves pediatric use of Dexcom’s G4 Platinum continuous glucose monitoring system
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.
FDA proposes rule to prevent food safety risks during transportation
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.
FDA Approves Hetlioz: first treatment for non-24 hour sleep-wake disorder in blind individuals
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 the disorder.
FDA Statement on Western Sugar Cooperative voluntary recall of beet pulp and tailings
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.
FDA prohibits Ranbaxy’s Toansa, India facility from producing and distributing drugs for the U.S. market
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.
FDA launches advisory committee membership nomination portal
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.
FDA warns consumers not to eat oysters from Copano Bay in Aransas County, Texas
• 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.
FDA Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor’s Statement on the Institute of Medicine Report on Caffeine in Food and Dietary Supplements
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 investigation of the safety of caffeine, particularly its effects on children and adolescents.