Press releases from FDA http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/PressReleases/rss.xml en-us Thu, 19 Nov 2009 15:50:00 -0500 tina.gilliam@fda.hhs.gov The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues. Thu, 19 Nov 2009 15:50:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191446.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191446.htm The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products. Thu, 19 Nov 2009 10:54:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191330.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191330.htm On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md. The Decree prohibits the defendants from selling animals for slaughter for human consumption until they have implemented record keeping systems that will identify and track animals that have been treated with drugs. Wed, 18 Nov 2009 15:36:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191232.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191232.htm Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17. Wed, 18 Nov 2009 13:37:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191169.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191169.htm The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles. Tue, 17 Nov 2009 15:43:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191003.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm191003.htm The U.S. Food and Drug Administration (FDA) and Everyday Health today announced a collaboration that will expand the delivery of the agency’s vital consumer health information to the 30 million unique users who visit Everyday Health each month. This joint effort reflects FDA's emphasis on using innovative, technology-based strategies to carry out its mission of protecting and promoting the public health. Tue, 17 Nov 2009 11:17:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190875.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190875.htm The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC. Mon, 16 Nov 2009 14:24:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190783.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190783.htm The Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) today released a report from the Institute of Food Technologists (IFT), which recommends clear objectives be set for all users of a simpler, globally accepted food supply chain that can benefit from existing commercial systems. Fri, 13 Nov 2009 15:37:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190564.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190564.htm The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot. Fri, 13 Nov 2009 15:16:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190551.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190551.htm Several weeks ago, the FDA announced its intent to change, by summer 2011, its policy regarding the post-harvest processing of raw Gulf Coast oysters harvested in the warmer months. The intent of this change in policy, which would affect about 25% of the total annual harvest, would be to substantially reduce the number of Americans who suffer severe and painful illness and death from the Vibrio vulnificus bacteria. The FDA's announced change in policy was modeled on a successful California initiative that was implemented in 2003. Fri, 13 Nov 2009 14:30:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190513.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190513.htm The U.S. Food and Drug Administration today cleared for marketing the Platelet PGD Test System, the first rapid test for the detection of bacterial contamination in pooled platelets derived from whole blood. Fri, 13 Nov 2009 13:11:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190490.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190490.htm The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products. Fri, 13 Nov 2009 10:26:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190427.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190427.htm The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against seafood processor Haifa Smoked Fish Inc. of Jamaica, N.Y., and two of its top officers for violations of the Federal Food, Drug and Cosmetic Act. Fri, 13 Nov 2009 10:08:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190421.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190421.htm Toan Le, 51, and Hang Ho, 41, a married couple residing in Burien, Washington, pleaded guilty today in U.S. District Court in Seattle in connection with their attempt to import and use a cosmetic device that had not been approved for use in the U.S. by the Food and Drug Administration. LE pleaded guilty to providing an Illegal Gratuity to Public Official and HO pleaded guilty to Introduction or Delivery for Introduction Into Interstate Commerce of Adulterated Device. When sentenced by U.S. District Judge Ricardo S. Martinez, LE faces up to two years in prison and HO faces up to one year in prison. Fri, 13 Nov 2009 00:00:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190661.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190661.htm The U.S. Food and Drug Administration has approved the use of the CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older. Thu, 12 Nov 2009 16:58:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190359.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190359.htm Ming Yan, who operates a computer store in North Providence, has pleaded guilty to causing the misbranding of the prescription drug sildenafil citrate, which is marketed as Viagara, and to copyright infringement. Immigration and FDA agents seized counterfeit sildenafil citrate pills and more than 1,000 pirated movie DVDs from Yan’s store and home in March 2008. Thu, 12 Nov 2009 00:00:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190606.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm190606.htm Dr. Margaret Hamburg, Commissioner of Food and Drugs, today sent a letter to America’s doctors thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on the safety of the 2009 H1N1 vaccines. Tue, 10 Nov 2009 09:17:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189676.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189676.htm Cutaneous T-cell lymphoma affects about 1,500 Americans annually The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL). Mon, 09 Nov 2009 16:01:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189629.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189629.htm Updated code is a model for state, city, county, tribal, territorial agencies and industry. The Food and Drug Administration today announced the publication of the new FDA Food Code, a model code and reference document that provides a scientifically sound technical and legal basis for regulating the retail and food service segment of the food industry. The 2009 FDA Food Code is a key component of the President’s overall public-health-focused food safety framework for maintaining a safe food supply. Mon, 09 Nov 2009 14:42:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189598.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189598.htm The U.S. Food and Drug Administration is enforcing the flavored cigarette ban provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) by issuing several warning letters to companies continuing to sell illegal flavored cigarettes to consumers in the United States through their Web sites. Fri, 06 Nov 2009 10:36:00 -0500 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189436.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm189436.htm