Press releases from FDA http://www.fda.gov en-us Wed, 15 Jan 2009 16:40:00 GMT tina.gilliam@fda.hhs.gov The U.S. Food and Drug Administration today issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain. Wed, 15 Jan 2009 16:40:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01945.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01945.html The U.S. Food and Drug Administration today issued a final guidance for industry on the regulation of genetically engineered (GE) animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act (FFDCA). The guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," clarifies the FDA's statutory and regulatory authority, and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law. Wed, 15 Jan 2009 14:30:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01944.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01944.html The U.S. Food and Drug Administration today announced the launch of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States. Wed, 14 Jan 2009 13:35:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01943.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01943.html Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., today announced the appointments of Lou Valdez as associate commissioner for international programs, and of Lori Davis as chief information officer. Mon, 12 Jan 2009 22:18:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01942.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01942.html The U. S. Departments of Health and Human Services, Agriculture, Commerce, Homeland Security, and Transportation and the U.S. Consumer Product Safety Commission, the U.S. Environmental Protection Agency, and the Office of the U.S. Trade Representative today issued draft guidance for industry titled "Good Importer Practices." The guidance is designed to provide guidance to importers on steps they can take to help ensure imported products are in compliance with applicable U.S. statutes and regulations. Mon, 12 Jan 2009 22:18:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01941.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01941.html The U.S. Food and Drug Administration announced that it had filed a Consent Decree on December 23, 2008, and currently awaits the court's entry of a permanent injunction that bars Actavis Totowa, LLC, Actavis, Inc., and their officers, Sigurdur Oli Olafsson and Douglas Boothe, from manufacturing and distributing drugs at the Actavis Totowa facilities. The injunction will remain in effect until Actavis Totowa comes into compliance with U.S. current Good Manufacturing Practice (cGMP) requirements, and obtains FDA's approval to manufacture and distribute drugs in the United States. The companies and their officers had also been manufacturing and distributing unapproved drugs in the United States. Fri, 09 Jan 2009 16:25:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01940.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01940.html The U.S. Food and Drug Administration announced today that the District Court for the District of New Mexico has enjoined Do-Rene and Clover Knolls Dairies and their owners, Douglas B. Handley and Irene Handley, from adulterating new animal drugs and introducing adulterated food into commerce. Both companies are based in Clovis, N.M. Fri, 02 Jan 2009 14:22:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01938.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01938.html The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif. Fri, 02 Jan 2009 14:22:00 GMT http://www.fda.gov/bbs/topics/NEWS/2009/NEW01937.html http://www.fda.gov/bbs/topics/NEWS/2009/NEW01937.html The U.S. Food and Drug Administration today approved the cobas TaqScreen MPX Test, the first nucleic acid test that screens for the presence of two divergent types of HIV in donated blood plasma and tissue. Tue, 30 Dec 2008 22:51:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01936.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01936.html The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer. Mon, 29 Dec 2008 15:32:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01935.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01935.html The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels. Wed, 24 Dec 2008 17:25:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01934.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01934.html The U.S. Food and Drug Administration is alerting consumers nationwide not to purchase or consume more than 25 different products marketed for weight loss because they contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. Mon, 22 Dec 2008 19:36:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html The U.S. Food and Drug Administration announced today that the District Court for the Western District of Missouri entered a Consent Decree on Dec. 15, 2008, prohibiting Milbank Mills, an animal feed mill in Chillicothe, Mo., from manufacturing, processing, or distributing medicated animal feed. Milbank Mills and its officers Edward P. Milbank and Darrell L. Allen, face these restrictions until they comply with current Good Manufacturing Practice (cGMP) requirements for medicated animal feeds. Mon, 22 Dec 2008 17:09:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01932.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01932.html The U.S. Food and Drug Administration today approved Gleevec (imatinib mesylate) for a new indication – keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST. Fri, 19 Dec 2008 23:59:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01931.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01931.html The General Services Administration's National Capital Region (GSA/NCR), the U.S. Department of Health and Human Services (HHS), and the HHS Food and Drug Administration (FDA) today dedicated historic Building One at the White Oak Federal Research Center in Silver Spring, Md. Thu, 18 Dec 2008 22:42:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01930.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01930.html The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Thu, 18 Dec 2008 20:18:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01929.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01929.html The U.S. Food and Drug Administration recommended today that manufacturers developing new drugs and biologics for type 2 diabetes provide evidence that the therapy will not increase the risk of such cardiovascular events as a heart attack. The recommendation is part of a new guidance for industry that applies to all diabetes drugs currently under development. Wed, 17 Dec 2008 18:56:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01928.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01928.html The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). Tue, 16 Dec 2008 21:17:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01927.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01927.html A study released today by the U.S. Food and Drug Administration found that the printed consumer medication information (CMI) voluntarily provided with new prescriptions by retail pharmacies does not consistently provide easy-to-read, understandable information about the use and risks of medications. Tue, 16 Dec 2008 17:23:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01926.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01926.html The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death. Mon, 15 Dec 2008 20:11:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01925.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01925.html The U.S. Food and Drug Administration is warning retailers and food service operators not to offer for sale ungutted, salt-cured alewives (also called gaspereaux fish) from Michel and Charles LeBlanc Fisheries Ltd., CAP-PELE, New Brunswick, Canada, because the fish may contain the Clostridium botulinum (C. botulinum) toxin. Consumers should not consume the product. Fri, 12 Dec 2008 21:39:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01924.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01924.html Today, the U.S. Food and Drug Administration announced that it will add a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney injury). Patients routinely take OSP products to cleanse the bowel before a colonoscopy (colon examination) and other medical procedures. Thu, 11 Dec 2008 19:32:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01923.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01923.html 'FDA Patient Safety News,' the FDA's monthly video series for health care professionals, has won the Cheers Award from the Institute for Safe Medication Practices (ISMP) for efforts to improve the safe use of medical products and prevent medical errors. Tue, 09 Dec 2008 21:31:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01922.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01922.html The U.S. Food and Drug Administration today announced that Wilderness Family Naturals LLC of Silver Bay, Minn., and its owners have signed a consent decree that prohibits them from manufacturing and distributing any products with unapproved claims that the products cure, treat, mitigate or prevent diseases. Tue, 09 Dec 2008 20:50:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01921.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01921.html The U.S. government announced today that there is no food or feed safety concern from an incident in which a small portion of an unauthorized genetically engineered (GE) cotton variety was harvested along with commercially available GE cotton. Wed, 03 Dec 2008 22:13:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01920.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01920.html The U.S. Food and Drug Administration today announced the participants in Phase II of its pilot program for voluntary third-party certification programs for imported aquacultured shrimp. Wed, 03 Dec 2008 17:30:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01919.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01919.html The U.S. Food and Drug Administration and WebMD today announced a collaboration that expands consumers' access to the agency's timely and reliable important health information. This joint effort reflects the FDA's emphasis on using innovative, technology-based strategies to carry out its foremost mission, which is to promote and to protect the public health. Wed, 03 Dec 2008 12:50:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01918.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01918.html The U.S. Food and Drug Administration today released a report on its implementation of the Food Protection Plan that was launched a year ago to protect both domestic and imported food from accidental and intentional contamination. The Plan, which outlines strategies for prevention, intervention and response, is designed to address food safety and food defense for both domestic and imported products and covers the full lifecycle of food, by encouraging the building of safety into every step of the food supply chain. Mon, 01 Dec 2008 13:14:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01917.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01917.html The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Mon, 24 Nov 2008 17:30:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01916.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01916.html The U.S. Food and Drug Administration today issued an expedited approval of a supplemental application that allows for changes in the manufacturing of Sucraid (sacrosidase) Oral Solution. Fri, 21 Nov 2008 00:50:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01915.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01915.html The U.S. Food and Drug Administration has approved a new drug, Banzel (rufinamide), for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome. Thu, 20 Nov 2008 22:50:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01914.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01914.html The U.S. Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as "FDA special agents" or other FDA officials. Wed, 12 Nov 2008 17:36:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01913.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01913.html The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity. Thu, 06 Nov 2008 17:04:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01912.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01912.html The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death. Wed, 05 Nov 2008 23:31:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB. Fri, 31 Oct 2008 16:49:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01910.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01910.html Marketed by Macleods Pharmaceuticals, Ltd, of Kachigam, Daman, in the Republic of India, the 75th drug is 150 milligram and 300 milligram tablets of generic lamivudine, a nucleoside analog reverse-transcriptase inhibitor (nRTI), which blocks an enzyme called reverse transcriptase, important to HIV production. HIV-infected patients who take lamivudine with other anti-HIV treatments develop less opportunistic infections. Wed, 29 Oct 2008 20:30:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01909.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01909.html The subcommittee report to the Science Board raises important questions regarding the draft safety assessment, and the FDA looks forward to the review of the subcommittee's report by the Science Board on Oct 31. Tue, 28 Oct 2008 23:59:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01908.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01908.html The U.S. Food and Drug Administration today sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products — Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage). Tue, 28 Oct 2008 14:15:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01907.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01907.html The U.S. Food and Drug Administration today approved an implantable and removable valve system designed to control some air leaks in the lungs that persist after certain kinds of lung surgery. Fri, 24 Oct 2008 19:57:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01906.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01906.html The U.S. Food and Drug Administration announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS. Thu, 16 Oct 2008 20:33:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01905.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01905.html Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration's Web site to find a wide variety of safety information about prescription drugs Wed, 15 Oct 2008 20:00:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01904.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01904.html The U.S. Food and Drug Administration today licensed for marketing the first product in the United States intended to protect people with hereditary angioedema (HAE), a rare and potentially life-threatening genetic disease. HAE affects about 6,000 to 10,000 individuals in the United States. Fri, 10 Oct 2008 21:05:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01903.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01903.html The U.S. Food and Drug Administration today approved Rapaflo (silodosin) capsules for the treatment of symptoms due to benign prostatic hyperplasia (BPH), a condition also known as an enlarged prostate. Fri, 10 Oct 2008 19:44:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01902.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01902.html Today the U.S. Food and Drug Administration in collaboration with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture launched its food defense awareness training kit for first line food industry employees. The training targets these individuals because they can play an important role in helping to keep our nation's food supply safe, from the farm to the table. Fri, 10 Oct 2008 19:44:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01901.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01901.html The U.S. Food and Drug Administration today approved a new use for the blood product Kogenate FS to reduce the frequency of bleeding episodes and prevent joint damage in children with the most severe form of hemophilia. Fri, 10 Oct 2008 16:51:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01900.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01900.html The steps that are being taken by CHPA will not affect the availability of the medicines, but this voluntary action will result in a transition period where the instructions for use of some OTC cough and cold medicines in children will be different from others. FDA does not typically request removal of OTC products with previous labeling from the shelves during a voluntary label change such as this one. Therefore, some medicines will have the new recommendation "do not use" for children under 4 years of age, while others will instruct that they not be used for children under 2 years of age. If parents or caregivers have or purchase a product that does not have the voluntarily-modified labeling, FDA recommends that they should adhere to the dosage instructions and warnings on the label that accompanies the medication. They should not, under any circumstances, give adult medications to children. If parents or caregivers have questions or are just not sure about how to use a product, they should consult with their doctor or pharmacist. Thu, 09 Oct 2008 08:14:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01899.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01899.html The U.S. Food and Drug Administration approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of their heart. Heart assist devices are mechanical pumps that aid in the pumping action of a weakened heart. Most heart assist devices support the heart's left ventricle, which pumps oxygen-rich blood to the rest of the body. The CentriMag Right Ventricular Assist System is intended for patients requiring support for the heart's right ventricle, which passes oxygen-depleted blood to the lungs to be refreshed with oxygen. Tue, 07 Oct 2008 17:48:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01898.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01898.html The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. Tue, 07 Oct 2008 15:24:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01897.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01897.html The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA's on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service. Mon, 06 Oct 2008 17:10:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01896.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01896.html The U.S. Food and Drug Administration (FDA) today issued the results of its interim safety and risk assessment of melamine and melamine-related compounds in food, including infant formula. Fri, 03 Oct 2008 13:10:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01895.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01895.html The U.S. Food and Drug Administration today announced the awarding of 17 grants to enhance food and feed safety. These grants fund major cooperative agreements in four major areas. The FDA awarded a combined $5.2 million in these one-year grants to various state and local regulatory agencies. Tue, 30 Sep 2008 22:11:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01894.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01894.html The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years. Tue, 30 Sep 2008 22:11:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01893.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01893.html A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as Lou Gehrig's Disease. Mon, 29 Sep 2008 20:16:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01892.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01892.html The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. Fri, 26 Sep 2008 15:28:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01891.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01891.html The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses. Tue, 23 Sep 2008 15:30:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01890.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01890.html The U.S. Food and Drug Administration today issued a proposed rule designed to reduce a practice known as "port shopping" which puts the safety of imported food at risk. Thu, 18 Sep 2008 15:17:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01888.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01888.html The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals. Thu, 18 Sep 2008 14:00:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01887.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01887.html The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States. Tue, 16 Sep 2008 18:30:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01886.html The U.S. Food and Drug Administration today announced the approval of the vaccine Gardasil for the prevention of vaginal and vulvar cancer caused by Human Papillomavirus (HPV) types 16 and 18 in girls and women ages 9 to 26. These two HPV types cause 70 percent of cervical cancers, and are known to also cause some vulvar and vaginal cancers, but the percentages are not well defined. Fri, 12 Sep 2008 21:39:00 GMT http://www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html http://www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html