http://www.compliancehome.com/ ComplianceHome is one of the Web's largest library of resources for compliance management of HIPAA, SOX, FISMA, PCI, GLBA, FDA, Basel II, OSHA and ISO 27002/17799. Visit our directories which are the best source on White papers, related news articles, resources on the web, training, webinars, conferences, rules & regulation overview, ask the expert, job and search on vendors, solutions & products. http://www.compliancehome.com/images/rsslogo.gif http://www.compliancehome.com/ en-us Fri, 19 Mar 2010 00:00:00 CST http://www.compliancehome.com/news/FDA/17403.html Carbaglu (carglumic acid) Tablets to treat a condition that results in too much ammonia in the blood gets consent from the U.S. Food and Drug Administration. The condition, N-acetylglutamate synthase or NAGS deficiency, is an extremely rare, genetic disorder that can be present in babies soon after birth. NAGS deficiency and the resulting elevated levels of ammonia (hyperammonemia) can be fatal if it is not detected and treated rapidly. DNA testing can confirm the diagnosis of NAGS. http://www.compliancehome.com/news/FDA/17403.html Tue, 16 Mar 2010 00:00:00 CST http://www.compliancehome.com/news/FDA/17388.html Located at HemroidsHemorrhoids.com, Consumer Health Reports has released their latest report on the best hemorrhoid treatment on the market. With all the treatments for hemorrhoids available to consumers. http://www.compliancehome.com/news/FDA/17388.html Tue, 15 Dec 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/16868.html The U.S. Food and Drug Administration , as a part of its ongoing effort to support food and medical product safety in this country by working with its regulatory partners overseas, announced the opening of its Mexico City post. This is the Agencys third post in Latin America and its tenth international post in the past 13 months. http://www.compliancehome.com/news/FDA/16868.html Sat, 28 Nov 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/16724.html The U.S. Food and Drug Administration today approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B. Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDAs accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner. In this case, Novartis demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza. http://www.compliancehome.com/news/FDA/16724.html Thu, 19 Nov 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/16654.html 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 on Nov. 16, 2009. The Decree forbids 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. http://www.compliancehome.com/news/FDA/16654.html Mon, 09 Nov 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/16581.html The Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) announced a joint public meeting focused on improving the system for tracing of food products and ingredients that are causing illness outbreaks or presenting other risks to the health of consumers. Recognizing the need to increase the speed and accuracy of traceback investigations and traceforward operations, both agencies are building on existing efforts by seeking public input that would help identify elements of effective food product tracing systems, identify current gaps in food product tracing, and suggest specific mechanisms for improvements. http://www.compliancehome.com/news/FDA/16581.html Fri, 09 Oct 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/16397.html Berinert, the first treatment for severe abdominal attacks and facial swelling associated with a rare and potentially life-threatening genetic disease called hereditary angioedema (HAE) gets consent from the U.S. Food and Drug Administration.Berinert is approved for adults and adolescents with HAE, which can occur spontaneously or during stress, surgery, or infection in patients diagnosed with HAE. The symptoms during abdominal attacks include severe abdominal pain, nausea, vomiting, cramps, and diarrhea. http://www.compliancehome.com/news/FDA/16397.html Sat, 03 Oct 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/16349.html Diversified Information Technologies, a leading provider of document and information lifecycle solutions, announced today that its facility in Gordonsville, VA complies with 36 CFR part 1228, subpart K regulations. http://www.compliancehome.com/news/FDA/16349.html Fri, 25 Sep 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/16311.html Accellion, Inc. announced it was placed in the Leaders quadrant within Gartner, Inc.s 2009 Magic Quadrant for Managed File Transfer1. Accellions managed file transfer solutions are deployed in enterprises and government agencies around the globe to secure the transfer of files for protection of intellectual property and for ensuring compliance with regulations such as SOX, HIPAA, FDA and GLBA. http://www.compliancehome.com/news/FDA/16311.html Mon, 21 Sep 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/16263.html Science is a key foundation for the decisions FDA makes daily on a wide-range of products affecting human and animal healthfrom the most common food ingredients, to complex medical and surgical devices, to lifesaving drugs. http://www.compliancehome.com/news/FDA/16263.html Wed, 29 Jul 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15967.html A final regulation classifying dental amalgam and its component parts elemental mercury and a powder alloyused in dental fillings is issued by the U.S. Food and Drug Administration. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients. http://www.compliancehome.com/news/FDA/15967.html Mon, 20 Jul 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15917.html The U.S. Food and Drug Administration announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States. The seasonal influenza vaccine will not protect against the 2009 H1N1 influenza virus that resulted in the declaration of a pandemic by the World Health Organization (WHO) on June 11, 2009. The FDA continues to work with manufacturers, international partners and other government agencies to facilitate the availability of a safe and effective vaccine against the 2009 H1N1 influenza virus. Although this years seasonal vaccine is directed against other strains of influenza expected to be circulating and will not provide protection against the 2009 H1N1 influenza virus, it is still important for those Americans for whom it is recommended to receive the seasonal influenza vaccine. No vaccine is 100 percent effective against preventing disease, but vaccination is the best protection against influenza and can prevent many illnesses and deaths. http://www.compliancehome.com/news/FDA/15917.html Tue, 14 Jul 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15887.html The U.S. Food and Drug Administration today issued draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug. The draft guidance is an important step in working with manufacturers to make drug products more difficult to duplicate by counterfeiters. The agency invites comments on the draft guidance, available online and titled Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting. http://www.compliancehome.com/news/FDA/15887.html Sat, 11 Jul 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15879.html The U.S. Food and Drug Administration has approved the blood-thinning drug Effient tablets (prasugrel) to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery. During an angioplasty, a balloon is used to open the artery that has been narrowed by atherosclerotic plaque. Often, a tiny wire mesh scaffold (stent) is inserted into the blood vessel to help keep the artery open after the procedure. Platelets in the blood can clump around the procedure site, causing clots that can lead to heart attack, stroke, and death. http://www.compliancehome.com/news/FDA/15879.html Mon, 06 Jul 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15849.html Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer has been approved by the U.S. Food and Drug Administration. Patients with cancer often receive maintenance therapy to prevent the disease from progressing after their tumor has shrunk or the disease has stabilized in response to chemotherapy. Alimta disrupts metabolic processes that are dependent on the B-vitamin folate, a necessary ingredient for cell replication. http://www.compliancehome.com/news/FDA/15849.html Mon, 06 Jul 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15845.html The U.S. Food and Drug Administration is warning consumers not to buy or use Hardcore Energize Bullet or New Whey liquid products sold in test tube-like vials due to suspected product tampering. The products are being recalled. The suspected tampering involved a utility knife blade found in one vial of Hardcore Energize Bullet drink, manufactured in the United States and sold in Canada, and another blade in one vial of New Whey liquid products, manufactured and sold in the United States. No one is known to have been hurt. http://www.compliancehome.com/news/FDA/15845.html Thu, 25 Jun 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15795.html The first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg gets the approval from the U.S. Food and Drug Administration. The generic product will be available by prescription only for women ages 17 and under. http://www.compliancehome.com/news/FDA/15795.html Wed, 17 Jun 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15743.html The U.S. Food and Drug Administration is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures. Consumers who do not follow instructions for contact lens care and use increase their risk of serious eye infections that can lead to blindness. http://www.compliancehome.com/news/FDA/15743.html Mon, 15 Jun 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15730.html The U.S. Food and Drug Administration has learned that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. have reappeared and are being sold in the U.S. market. Three lots or a total of 129,000 vials of this product were stolen in all. These stolen insulin vials may not have been stored and handled properly and may be dangerous for patients to use. http://www.compliancehome.com/news/FDA/15730.html Sat, 30 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15650.html A renowned oncologist at the U.S. Food and Drug Administration, Richard Pazdur, M.D., is recognized by the worlds largest cancer professional society.The American Society of Clinical Oncology (ASCO) is presenting Pazdur with its Special Recognition Award for his achievements in cancer drug development and his outstanding service to the oncology community. Janet Woodcock, M.D., director of the FDAs Center for Drug Evaluation and Research said, This is a well-deserved award for a world-class oncologist. Rick has worked tirelessly to ensure that safe and effective therapies are available as quickly as possible to treat patients with cancer. The FDA is fortunate to have him leading our efforts in cancer drug development. http://www.compliancehome.com/news/FDA/15650.html Mon, 25 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15613.html A biodefense company developing medical countermeasures against biological and chemical threats PharmAthene, Inc announced that the Company has submitted its comprehensive regulatory strategy to the U.S. Food and Drug Administration (FDA) outlining the non-clinical and clinical development plans for licensure of SparVax(TM), a next generation recombinant protective antigen anthrax vaccine.The FDA submission is in response to recent amendments issued by the Department of Health and Human Services (HHS) on April 15th and 22nd, 2009, to solicitation number RFP BARDA 08-15, outlining a requirement to develop and procure 25 million doses of a next generation rPA anthrax vaccine for the country's civilian biomedical stockpile. http://www.compliancehome.com/news/FDA/15613.html Sat, 23 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15609.html Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood have been approved by the U.S. Food and Drug Administration. With the approval of Samsca, physicians will have an additional tool to treat hyponatremia, said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Products in the FDAs Center for Drug Evaluation and Research. http://www.compliancehome.com/news/FDA/15609.html Wed, 13 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15528.html The consumers are being constantly advised by the Food and Drug Administration to stop using certain cosmetic Face Paint items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide. The FDA has learned of a cluster of adverse events in children exposed to various colors of the face paint. All exposures occurred on the same day at an organized event and included rashes, itchiness, burning sensation, and swelling where the face paints were applied. Significant microbial contamination was indicated in most of the products in testing by an FDA laboratory. http://www.compliancehome.com/news/FDA/15528.html Tue, 12 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15517.html The U.S. District Court for the Eastern District of Michigan, Southern Division, entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements. The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury, said Michael Chappell, FDAs acting associate commissioner for regulatory affairs. It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace. http://www.compliancehome.com/news/FDA/15517.html Fri, 08 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15506.html The U.S. Food and Drug Administration gives its approval to Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy. GBM is a rapidly progressing cancer that invades brain tissue and can impact physical activities and mental abilities. It affects about 6,700 persons in the United States every year. Following initial treatment with surgery, radiation, and/or chemotherapy, the cancer nearly always returns. http://www.compliancehome.com/news/FDA/15506.html Fri, 08 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15503.html A budget of $3.2 billion is being requested by the U.S. Food and Drug Administration to shield and promote the public health as part of the Presidents fiscal year (FY) 2010 budget a 19 percent increase over the current FDA fiscal year budget. The FY 2010 request, which covers the period of Oct. 1, 2009, through Sept. 30, 2010, includes increases of $295.2 million in budget authority and $215.4 million in industry user fees. http://www.compliancehome.com/news/FDA/15503.html Thu, 07 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15487.html The U.S. Food and Drug Administration (FDA) announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain. As part of its overall pandemic influenza preparedness efforts, the FDA meets with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities that comply with agency requirements. The agency promptly reviews applications and manufacturing supplements that could increase both the number of manufacturers and the overall supply of vaccine. http://www.compliancehome.com/news/FDA/15487.html Fri, 01 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15455.html Consumers are being warned by the U.S. Food and Drug Administration to right away stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market. The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure. http://www.compliancehome.com/news/FDA/15455.html Fri, 01 May 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15450.html Incited by reports of serious adverse events, the U.S. Food and Drug Administration today announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products. The agency said it took the action because of reports that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism, including unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. http://www.compliancehome.com/news/FDA/15450.html Wed, 29 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15428.html A final rule that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs is issued by the Food and Drug Administration.FDA action covered the products like Acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers. http://www.compliancehome.com/news/FDA/15428.html Tue, 28 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15413.html In response to requests from the U.S. Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances. The agency issued these EUAs for the use of certain Relenza and Tamiflu antiviral products, and for the rRT-PCR Swine Flu Panel diagnostic test. http://www.compliancehome.com/news/FDA/15413.html Mon, 27 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15401.html The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommended that consumers not eat raw alfalfa sprouts, including sprout blends containing alfalfa sprouts, until further notice because the product has been linked to Salmonella serotype Saintpaul contamination. Other types of sprouts have not been implicated at this time. Its been indicate through the investigations that the problem may be linked to contamination of seeds for alfalfa sprouts. Because suspect lots of seeds may be sold around the country and may account for a large proportion of the alfalfa seeds currently being used by sprout growers, and cases of illness are spread across multiple states, FDA and CDC are issuing this general advisory. http://www.compliancehome.com/news/FDA/15401.html Sun, 26 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15400.html Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis is approved by the U.S. Food and Drug Administration. All three conditions are chronic disorders in which the immune system attacks multiple joints, causing stiffness, pain, and restricted motion.Todays approval provides another treatment option for patients with these three debilitating disorders, said Bob Rappaport, M.D., director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDAs Center for Drug Evaluation and Research. And the steps were taking to minimize the risks will give patients the same level of safety protection required for other drugs in its class. http://www.compliancehome.com/news/FDA/15400.html Sun, 26 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15397.html New Envirosealed TECStation 1806 workstation of CCS-Inc. will be unveiled at this years Food Safety Summit in Washington, D.C. This rugged workstation is compact and allows for easy maintenance on the plant floor. The NEMA 4X Stainless Steel Enclosure is built to provide high-tech computing solutions in harsh environments. The unit has a 19 APR touchscreen display that is built to withstand predisposed environmental damage such as dust, dirt, chemicals, and scratching. APR touchscreen technology provides a clear, high-quality, non-reflective display. The stations dimensions allow for maximum screen exposure while minimizing the enclosures overall footprint. http://www.compliancehome.com/news/FDA/15397.html Wed, 22 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15355.html It is better explained by the findings of the U.S. Food and Drug Administration scientists and collaborators what part of the bird flu virus is seen by the immune system once a person becomes infected. As one result of this research, a protein of the bird flu virus called PB1-F2 was identified as a potentially potent target for attack by immune systems to stop the spread of the virus. Analysis of blood from patients recovering from the H5N1 avian influenza virus can lead to new tools for testing the potential protective activity of vaccines under development, said Karen Midthun, M.D., acting director of the FDAs Center for Biologics Evaluation and Research (CBER). The findings could also lead to new tests to detect infections, and improved therapies. http://www.compliancehome.com/news/FDA/15355.html Fri, 17 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15313.html The Oral Cancer Foundation called for the U.S. Senate to grant the U.S. Food and Drug Administration (FDA) authority over tobacco products in response to the tobacco industry's most aggressive marketing campaign targeted at women and girls in over a decade. All most two weeks ago the U.S. House of Representatives voted to give the FDA such authority. http://www.compliancehome.com/news/FDA/15313.html Wed, 15 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15285.html Coast IRB, LLC of Colorado Springs, Colo., has agreed to willingly stop some aspects of its clinical trial oversight operations due to serious concerns about the company's ability to protect human subjects participating in clinical trials, announced by the U.S Food and Drug Administration As per the records of the company, these actions may involve approximately 300 active human research studies conducted by some 3,000 clinical investigators. http://www.compliancehome.com/news/FDA/15285.html Sat, 11 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15272.html The U.S Food and Drug Administration modified its March 30, 2009, action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis.This action is taken by FDA in response to concerns from patients and health care professionals in the palliative care community that the action taken on March 30 would cause a shortage of 20 mg/ml morphine sulfate oral solution. This product is widely used to alleviate pain in terminally-ill patients. The agency has determined that this dosage form is medically necessary, and should remain on the market until an approved alternative becomes available to the patients that need it. http://www.compliancehome.com/news/FDA/15272.html Thu, 09 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15255.html The manufacturer of the psoriasis drug Raptiva (efalizumab), Genentech, announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. Because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, the company has decided to take this action. Raptiva will no longer be available in the United States. http://www.compliancehome.com/news/FDA/15255.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15252.html Engineering Regulatory Compliance. Attend two-day seminars, planned and delivered by subject matter experts who work in the field every day. Topics include: barrier isolation, product quality lifecycle implementation, packaging challenges, C&Q and validation inclusive of computer systems validation; applied risk management, global supply chain security, renovation, and GAMP GPG on PCS Ver. 2 and Calibration Guide, Ver. 2. http://www.compliancehome.com/news/FDA/15252.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15251.html The FDA made an announcement that manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and valuable information to the agency so that it may assess the risk level for each device type. Devices found by the FDA to be of high risk to consumers will be required to undergo the agencys most stringent premarket review process.The device types, which are listed in the Federal Register announcement posted, 25 in number were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976. That law authorized the FDA to review new medical devices. Todays announcement is the first step towards completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accountability Office (GAO) in a January 2009 report to Congress. http://www.compliancehome.com/news/FDA/15251.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15250.html U.S. Marshals at the request of the U.S. Food and Drug Administration, implemented an inspection warrant at Westco Fruit and Nuts Inc. (Westco/Westcott), an Irvington, N.J.-based company. Westco/Westcott did not provide access to distribution documents and declined to recall products after an FDA request. Regulated companies are required by law to grant FDA entry for inspection, as well as provide access to distribution records. The FDA does not have authority to compel companies to recall food products, such as peanuts. http://www.compliancehome.com/news/FDA/15250.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15249.html Coartem tablets (artemether and lumefantrine) for the treatment of severe, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds) have been approved by the U.S. Food and Drug Administration.Malaria is a global life-threatening disease, said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA. It is encouraging to have new treatment available, particularly for children. http://www.compliancehome.com/news/FDA/15249.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15242.html With an immense increase in mans intellect, the technology that was once considered not viable is now being made available. Everyone has known someone that is in need of some type of surgery. Patients have become savvier in their search for treatment of whatever ails them. In doing that, doctors are constantly raising the bar when it comes to improving surgical procedures. One of the most groundbreaking procedures that is now being made available in a handful of hospitals across the country is the Gamma Knife procedure. http://www.compliancehome.com/news/FDA/15242.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15238.html The consumers are warned by FDA not to eat Strubs Norwegian Style Sliced Smoked Steelhead Salmon in 300 gram packages because of potential contamination with the bacterium Listeria monocytogenes. L. monocytogenes is a foodborne pathogen that can cause serious illness and death. The smoked steelhead salmon, distributed by West Side Foods Inc. of Bronx, N.Y., was imported from Canada, and 13 cartons were sold to three kosher retail stores in New York and Maryland. http://www.compliancehome.com/news/FDA/15238.html Wed, 08 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15237.html The U.S. Food and Drug Administration cleared for marketing a new, qick rapid test for the detection of influenza A/H5N1, a disease-causing subtype of the avian influenza A virus that can infect humans. The test, called AVantage A/H5N1 Flu Test, detects influenza A/H5N1 in throat or nose swabs collected from patients who have flu-like symptoms. The test identifies in less than 40 minutes a specific protein (NS1) that indicates the presence of the influenza A/H5N1 virus subtype. Tests previously cleared by the FDA to detect this influenza A virus subtype can take three or four hours to produce results. http://www.compliancehome.com/news/FDA/15237.html Mon, 06 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15220.html With immense pride, BiCOM Inc. presents its matchless Trans-palpebral and Tras-scleral tonometer Diaton to the American Society of Cataract and Refractive Surgery ASCRS on April 3th 8th, hosted by the city of San Francisco. With FDA approval, CE MARK and now Health Canada approval opens many international doors for BiCOM Inc., a global distributor of Diaton tonometers. Exhibition of Diaton tonometer to the members of American Society of Cataract and Refractive Surgery (ASCRS) presents the opportunity for BiCOM to display the incomparable unique qualities of trans-palpebral and tras-scleral Diaton tonometry tonometry through the Eyelid. http://www.compliancehome.com/news/FDA/15220.html Fri, 03 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15204.html The public is being alerted by the U.S. Food and Drug Administration (FDA) to a voluntary recall by Union International Food Company (Union City, Calif.) of the companys dry spice products. The recall is based on an investigation of an ongoing foodborne illness outbreak of Salmonella Rissen. This investigation is being conducted in collaboration with state health officials in California, Oregon, Nevada, Washington and the U.S. Centers for Disease Control and Prevention (CDC). The companys products are distributed in these states and Arizona. Lian How and Uncle Chen are the brand names under which the dry spices being recalled were sold primarily to ethnic restaurants, wholesalers, and retail outlets. At this time, the distribution of products appears confined to the western region of the country. http://www.compliancehome.com/news/FDA/15204.html Thu, 02 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15194.html Genentech, Inc. announced that the U.S. Food and Drug Administration Oncologic DrugsAdvisory Committee voted unanimously that the response seen with Avastin (bevacizumab) in people with previously treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit. The FDA is expected to make a decision whether to grant accelerated approval of Avastin for use in this most aggressive form of brain cancer by May 5, 2009. http://www.compliancehome.com/news/FDA/15194.html Wed, 01 Apr 2009 00:00:00 CST http://www.compliancehome.com/news/FDA/15192.html The first generic versions of Topamax tablets (topiramate) are approved by the U.S. Food and Drug Administration These tablets can be taken to prevent seizures. Generic drugs undergo a rigorous scientific review to ensure they will provide patients with the same dose of high quality, safe and effective active ingredient as the name brand product, said Gary Buehler, director of the Office of Generic Drugs in the Center for Drug Evaluation and Research. The FDA is committed to providing access to safe and effective generic drugs as soon as the law permits when a brand name drugs patents and exclusivities expire. http://www.compliancehome.com/news/FDA/15192.html