http://www.compliancehome.com/ ComplianceHome is one of the Web's largest library of resources for compliance management of HIPAA, SOX, FISMA, GLBA, FDA, COOP & COG, FFIEC, 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 Sun, 04 May 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12718.html As a result of a routine inspection of the Evangers Dog & Cat Food Company manufacturing facilities by the U.S. Food and Drug Administration, the FDA recently raised questions regarding recordkeeping and other issues at the pet food producers facilities. Contrary to a news release issued by the FDA Thursday, April 24, 2008, Evangers continues to make and distribute its products with FDA approval. Evangers is working closely with the FDA and already has addressed many of the FDAs questions. Evangers expects to have the few remaining FDA queries fully satisfied shortly. http://www.compliancehome.com/news/FDA/12718.html Wed, 30 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12701.html Worksoft, provider of solutions that accelerate deployments of SAP applications, announced that its flagship solution Worksoft Certify, can bridge the chasm between the processes of Governance, Risk and Compliance (GRC) and the processes of Application Life Cycle Management. Companies today are not only striving to improve their business processes, they must do so while grappling with compliance issues, said Bruce Johnson, president and CEO of Worksoft. Companies adhering to IT governance implications of Sarbanes-Oxley (SOX), or the required compliance of their respective industries, such as HIPAA and FDA, are looking for a way to shift governance from being a burden to helping them gain and sustain competitive advantages in a highly dynamic global economy. Worksoft can help manage the business process change events between the office of the CIO and the CEO/CFO by enabling timely collaboration and visibility. http://www.compliancehome.com/news/FDA/12701.html Tue, 29 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12699.html The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as mad cow disease). This FDA action serves to further protect the U.S. cattle population from the already low risk of BSE, said Dr. Bernadette Dunham, Director of FDA's Center for Veterinary Medicine. The new rule strengthens existing safeguards. The new measure builds on FDA's 1997 feed regulation, which prohibited the use of certain mammalian proteins in ruminant feed. http://www.compliancehome.com/news/FDA/12699.html Tue, 29 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12698.html The U.S. Food and Drug Administration today delivered recommendations to Congress for two programs that provide funding for the review of pioneer and generic animal drugs. If adopted by Congress, the Animal Drug User Fee Act (ADUFA) reauthorization would provide funding for the review of new animal drug applications for the next five years. In addition, the first generic user fee program (the Animal Generic Drug User Fee Act or AGDUFA) would support the review of generic animal drug applications and maintain current standards of safety and effectiveness. The funding is tied to meeting specific performance goals that will ensure efficient scientific evaluation of the safety and effectiveness of animal drugs. http://www.compliancehome.com/news/FDA/12698.html Tue, 29 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12697.html The U.S. Food and Drug Administration issued an order requiring that Evanger's Dog & Cat Food Co., Inc., in Wheeling, Ill., obtain an emergency permit from the FDA before its canned pet food products enter interstate commerce. A recent inspection revealed significant deviations from prescribed documentation of processes, equipment, and recordkeeping in the production of the company's thermally processed low acid canned food (LACF) products. These problems could result in under-processed pet foods, which can allow the survival and growth of Clostridium botulinum (C. botulinum), a bacterium that causes botulism in some animals as well as in humans. http://www.compliancehome.com/news/FDA/12697.html Tue, 29 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12696.html The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. Opioids are often prescribed on a continuous basis for patients with late-stage, advanced illness to help alleviate pain. This includes patients with a diagnosis of incurable cancer, end-stage Chronic Obstructive Pulmonary Disease (COPD) from emphysema, heart failure, Alzheimers disease with dementia, HIV/AIDS or other advanced illnesses. Opioids can interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from contracting and pushing out waste products. Relistor acts by blocking opioid entrance into the cells thus allowing the bowels to continue to function normally. http://www.compliancehome.com/news/FDA/12696.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12677.html SYSPRO, a provider of visionary ERP for the manufacturing pragmatist, has announced the availability of Document Management for SYSPRO, a cost-effective, green-minded solution set that enables mid-market manufacturers to gain new cost and time efficiencies while addressing regulatory compliance mandates. The new software continues SYSPRO's foray into innovations which provide environmentally friendly options for businesses; in this case aimed at growth-oriented visionary businesses who want to reduce paper, as well as gain new efficiencies. Document Management for SYSPRO, which is optionally available with enhanced workflow features, enables organizations to access, manage and automate the routing of all digital content, including scanned paper documents, e-mails, faxes, print streams, application files, e-forms, Web content and multimedia files. The solution is holistically embedded into SYSPRO's standard ERP solution set, enabling workers to access and manage these documents directly http://www.compliancehome.com/news/FDA/12677.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12674.html The U.S. Food and Drug Administration approved a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant. Heart assist devices are surgically implanted mechanical pumps that help the heart's ventricle do its work of pumping blood to the rest of the body. Previous models were too large to be placed in the upper abdomen of some women and small-sized men. But the Thoratec HeartMate II Left Ventricular Assist System employs a first-of-a-kind design. Instead of the standard pulsatile pump that simulates the action of the heart, the device uses a continuous flow pump that constantly moves blood with a single moving part, a spinning rotor. This allows the device to be slimmed down to a mere three inches in length and a weight of approximately one pound. http://www.compliancehome.com/news/FDA/12674.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12673.html A new drug has been approved to help sufferers of Crohn's disease, the U.S. Food and Drug Administration announced today. Cimzia (certolizumab pegol) received approval for adults with moderate to severe Crohn's disease who have not responded to conventional therapies. This product was approved with a Medication Guide. Crohn's disease is a chronic, inflammatory bowel disease that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Crohn's can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs. http://www.compliancehome.com/news/FDA/12673.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12672.html The U.S. Food and Drug Administration has cleared for marketing the first device made from a new form of natural rubber latex, guayule latex. The product, the Yulex Patient Examination Glove, is derived from the guayule bush, a desert plant native to the Southwestern United States. Traditional latex gloves are made from the milky sap of a rubber tree, Hevea braziliensis. The sap contains a protein that may trigger allergic reactions, especially after prolonged and repeated contact. Sensitized people may experience mild reactions such as skin redness, rash, hives, or itching. More severe reactions may include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, shock may occur. Estimates vary, but anywhere from 3 percent to 22 percent of all health care workers are sensitized to traditional latex. Available data on the new guayule latex show that even people who are highly allergic to traditional latex do not react on first exposure to guayule latex p http://www.compliancehome.com/news/FDA/12672.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12671.html The U.S. Food and Drug Administration today issued a final regulation barring certain cattle materials from all animal feed, including pet food. The final rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as mad cow disease). This FDA action serves to further protect the U.S. cattle population from the already low risk of BSE, said Dr. Bernadette Dunham, Director of FDAs Center for Veterinary Medicine. The new rule strengthens existing safeguards. The materials that can no longer be used in animal feed are the tissues that have the highest risk for carrying the agent thought to cause BSE. These high risk cattle materials are the brains and spinal cords from cattle 30 months of age and older. The entire carcass of cattle not inspected and passed for human consumption is also prohibited, unless the cattle are less than 30 months of age, or the brains and spinal cords have been removed. The risk of BSE in cattle less than 30 months http://www.compliancehome.com/news/FDA/12671.html Sun, 20 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12648.html With safety issues making headlines, pharmaceutical and medical device manufacturers face a rugged regulatory landscape. Organizations are relying on their quality function to navigate regulatory difficulties that could affect production. Proper staffing of quality roles is just one way organizations optimize their quality function and a study by pharmaceutical benchmarking leader Best Practices, LLC found best-in-class companies have a ratio of quality personnel to total manufacturing employees between 1:4 and 1:7. As captured in the benchmarking report, The Quality Function: Structure, Staffing and Execution, Best Practices, LLC, reveals strategic best practices in quality harnessed from survey responses and in-depth interviews with seven top pharmaceutical and medical device company leaders. http://www.compliancehome.com/news/FDA/12648.html Thu, 17 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12641.html CryoLife, a biomaterials, medical device and tissue processing company, announced that it has signed an exclusive three-year agreement with Minneapolis-based Medafor, Inc. Under terms of the agreement CryoLife will distribute Medafor's microporous polysaccharide hemostatic agent for use in cardiac and vascular surgery in the U.S. and for cardiac, vascular and general surgery, other than orthopaedic and ear, nose and throat surgery, outside the U.S. (excluding Japan and China). CryoLife expects to begin distributing Hemostase MPH in the U.S. in the second quarter of 2008, except to approximately 41 hospitals for which Medafor will retain distribution rights until no later than December 31, 2008. Outside of the U.S., CryoLife expects to begin distributing Hemostase MPH in Canada, United Kingdom and Germany in the second quarter of 2008, with distribution in other markets beginning in 2009. Department of Defense hospitals are excluded from CryoLife's territory under the distribution agree http://www.compliancehome.com/news/FDA/12641.html Thu, 10 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12588.html At the request of the U.S. Food and Drug Administration, today U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Natural Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act. The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that a consumer may already be taking. http://www.compliancehome.com/news/FDA/12588.html Thu, 10 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12587.html The U.S. Food and Drug Administration announced that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products Total Body Formula and Total Body Mega Formula. The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. On March 27, the FDA warned consumers not to purchase or use Total Body Formula in flavors Tropical Orange and Peach Nectar and Total Body Mega Formula in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee (www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html). The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. http://www.compliancehome.com/news/FDA/12587.html Sun, 06 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12546.html The U.S. Food and Drug Administration today announced the approval of Rotarix, the second oral U.S. licensed vaccine for the prevention of rotavirus, an infection that causes gastroenteritis (vomiting and diarrhea) in infants and children. Rotarix is a liquid and given in a two-dose series to infants from 6 to 24 weeks of age. Although the disease is usually self-limiting, rotavirus causes about 2.7 million cases of gastroenteritis in U.S. children each yearabout 55,000 to 70,000 of those require hospitalization; and between 20 and 60 deaths are attributed to it. Without vaccination, nearly every child in the United States would likely be infected at least once with rotavirus by age 5. There are many different strains of rotavirus. The vaccine protects against rotavirus gastroenteritis caused by the G1, G3, G4, and G9 strains. http://www.compliancehome.com/news/FDA/12546.html Sun, 06 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12545.html At the request of the U.S. Food and Drug Administration, on Wednesday U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders. The dietary supplements seized were marketed and distributed on-line and in retail stores under the names Methyl 1-D, Methyl 1-D XL, and Formadrol Extreme XL. http://www.compliancehome.com/news/FDA/12545.html Fri, 04 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12536.html Dermestetics Cosmeceuticals, a company known to push the envelope with technologically advanced skin care products has seen a rise in sales due to the recent FDA reports on botulinum. Dermaxin, a powerful, topical wrinkle-relaxant and collagen-booster has been flying off the shelves as consumers seek new safe but effective alternatives to eliminate wrinkles. Dermaxin poses no risk of side effects such as damaged nerves or in extreme cases death that botulinum can impose. The U.S. Food and Drug Administration notified the public February 8, 2008 about harmful side effects of Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B). These popular, medically administered injections have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses. Dermaxin is a safe alternative to treating the unwanted signs of aging including wrinkles, frown lines and loose http://www.compliancehome.com/news/FDA/12536.html Fri, 04 Apr 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12535.html The Lorillard Tobacco Company issued the following statement with regard to the passage of a bill by the House Committee on Energy and Commerce that would force the U.S. Food and Drug Administration (FDA) to regulate the tobacco industry. The Lorillard Tobacco Company opposes H.R. 1108 -- legislation that would force the FDA to regulate tobacco. While Lorillard fully supports reasonable federal regulation of the tobacco industry, the FDA already is overworked by Congress and is the wrong agency for the job. The challenges facing FDA are well documented. Adding a new industry for the FDA to oversee when it is struggling to fulfill its core mission is misguided. It will only compromise the health and safety of millions of Americans. http://www.compliancehome.com/news/FDA/12535.html Mon, 31 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12508.html Novartis Pharmaceuticals Corporation announced today the successful completion of a cooperative research and development agreement (CRADA) with the Food and Drug Administration (FDA), one of the first projects conducted under the FDA's Critical Path Initiative. The Critical Path Initiative was launched by FDA in 2004 to refine the science and processes through which FDA-regulated drugs, biologics, and devices are translated from a discovery or proof of concept to a medical product. The research produced under the CRADA led to a number of key achievements that will enhance the development and application of preclinical biomarkers to evaluate drug safety. In working together with FDA, we have demonstrated the progress that can be achieved in the biomarker field, and in the science of drug development in general, through public-private partnerships, according to John Orloff, MD, Senior Vice President, US Medical and Drug Regulatory Affairs at Novartis Pharmaceuticals Corporation. http://www.compliancehome.com/news/FDA/12508.html Wed, 26 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12493.html Congress has criticized the Food and Drug Administration (FDA) in the past year for not ensuring the safety of the nation's food, prescription drug and medical device supplies. Senior members of Congress have stated at various times, The health and safety of the American people is at risk... our food supply becomes more dangerous all the time... there is a fundamental breakdown for evaluating the safety of drugs... the FDA is badly broken. These sentiments are reflected in numerous national media stories describing a variety of FDA warnings on and recalls of food and drugs. In addition to elected officials, a scientific advisory panel recently reported that American lives are at risk due to the inability of FDA to oversee the safety of the food, drug and medical device supplies in the United States. http://www.compliancehome.com/news/FDA/12493.html Wed, 26 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12487.html Ingenuity Systems, provider of information solutions for life science researchers, announced it has achieved key milestones in the ongoing Cooperative Research and Development Agreement (CRADA) with the Food and Drug Administration. Significant progress has been made in several areas including the curation of new biomarker and toxicology content and the expansion of existing ontological classifications. These developments will advance the FDA towards its goal of rapidly identifying potential genomic 'fingerprints' that could be used to quickly and easily compare genomic data from submissions of drugs in the same class. Under the terms of the CRADA, Ingenuity Systems and the FDA will expand Ingenuity's content and software solutions to facilitate the research and regulatory review of biomarker, pharmacogenomic, and toxicogenomic data. The collaboration directly relates to the FDA's need to develop better tools for the review of genomic data. http://www.compliancehome.com/news/FDA/12487.html Wed, 26 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12486.html The U.S. Food and Drug Administration is advising consumers not to purchase or use Blue Steel or Hero products marketed as dietary supplements throughout the United States because they are considered unapproved drugs and have not been proven to be safe or effective. These products contain undeclared ingredients, which may dangerously affect a persons blood pressure level. These products are promoted and sold over the Internet for the treatment of erectile dysfunction (ED) and for sexual enhancement. Theyre touted as all natural and labeled as dietary supplements. However, Blue Steel and Hero products do not qualify as dietary supplements because they contain undeclared and unapproved substances that are similar in chemical structure to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED. http://www.compliancehome.com/news/FDA/12486.html Mon, 24 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12471.html FDA and State Interactions: Addressing Changes and Challenges for Food Supply Safety will be discussed during the final keynote presentation at the 10th Annual Food Safety & Security Summit taking place at the Washington, DC Convention Center. Panelists will include Kari Barrett, Senior Advisor, Food Protection, FDA/CFSAN; Capt. David Elder, Director of The Office of Enforcement within the Office of Regulatory Affairs, FDA; and Steve Steingart, CFSP, Industry Liaison/Assistant Chief, Alleghany County Health Department and President, Association of Food and Drug Officials (AFDO). Other key sessions on Wednesday include Food Allergen Monitoring & Risk Control; Trends and Interventions for Food Safety and Quality; Perishable Food Handling and Merchandising; Detecting New and Emerging Pathogens; Farm to Fork Traceability & Assurance; Crisis Management & Recall Strategies, and many others. http://www.compliancehome.com/news/FDA/12471.html Sun, 23 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12465.html The U.S. Food and Drug Administration today approved a new medical adhesive (a fibrin sealant) called Artiss for use in attaching skin grafts onto burn patients. Fibrin sealants are tissue adhesives that contain the proteins fibrinogen and thrombin, which are essential in the clotting of blood. Artiss (Fibrin Sealant, VH S/D 4) differs from other fibrin sealants in that it contains a lower concentration of thrombin. This lower concentration allows surgeons more time to position skin grafts over burns before the graft begins to adhere to the skin. Artiss also contains aprotinin, a synthetic protein that delays the break down of blood clots. The approval of Artiss can help surgeons using a fibrin sealant to fine tune graft placement on burn sites, said Jesse L. Goodman M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research. The approval also provides an additional choice for health care professionals in providing burn treatment. http://www.compliancehome.com/news/FDA/12465.html Sun, 23 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12464.html The U.S. Food and Drug Administration has issued an import alert regarding entry of cantaloupe from Agropecuaria Montelibano, a Honduran grower and packer, because, based on current information, fruit from this company appears to be associated with a Salmonella Litchfield outbreak in the United States and Canada. The import alert advises FDA field offices that all cantaloupes shipped to the United States by this company are to be detained. In addition, the FDA has contacted importers about this action and is advising U.S. grocers, food service operators, and produce processors to remove from their stock any cantaloupes from this company. The FDA also advises consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from this specific grower and packer. If so, consumers should throw away the cantaloupes. http://www.compliancehome.com/news/FDA/12464.html Tue, 18 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12437.html Global Research Services, LLC (GRS) entered into a strategic alliance with CardioDynamics. The agreement authorizes GRS to utilize CardioDynamics impedance cardiography (ICG) technology for advanced processing of noninvasive hemodynamic ICG data. CardioDynamics ICG products enable GRS to provide expanded biometrics and data management services in support of clinical trials. Combining the strengths of both companies will allow biotechnology, pharmaceutical, and device companies and clinical research sites to obtain the benefits of enhanced cardiac safety monitoring in Phase I through IV clinical trials. GRS has recently completed several programs using this state of the art technology to rapidly upload data from CardioDynamics proprietary BioZ ICG technology and BioZport application software. Investigators and sponsors can easily view reports and detailed cardiovascular tables and graphs created from real-time trial data through secure online portals, assisting in faster decisions re http://www.compliancehome.com/news/FDA/12437.html Mon, 17 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12434.html Genta Incorporated announced that the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has decided that available data are not adequate to support approval of Genasense (oblimersen sodium) Injection for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In a decision issued in response to an appeal filed by Genta in October 2007, CDER acknowledged that complete response, which was the primary endpoint in the pivotal trial, was an appropriate endpoint for assessing efficacy. FDA also agreed that this endpoint was achieved, and that those results supported the efficacy of the drug. However, CDER concluded that at present there was insufficient confirmatory evidence in the New Drug Application (NDA) to approve the drug. http://www.compliancehome.com/news/FDA/12434.html Tue, 11 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12405.html Duska Therapeutics, a biotechnology company developing medical products based on adenosine 5'-triphosphate (ATP) and P2 receptor-related technologies, announced today that its senior management and consultants are scheduled to meet with representatives of the U.S. Food and Drug Administration's (FDA) Division of Cardiovascular and Renal Products in April to discuss the regulatory pathway for obtaining marketing approval of ATPace, an intravenous formulation of ATP. Duska requested a Type C advisory meeting with the FDA to present, discuss and obtain answers to several questions submitted by the company related to the regulatory pathway of ATPace(tm). The company intends to file an NDA under Section 505(b)(2) of the FDA for ATPace(tm) as an antiarrhythmic drug for the conversion of paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm. The company believes that the meeting with the FDA will yield a pathway for eventual marketing approval of the drug. http://www.compliancehome.com/news/FDA/12405.html Mon, 10 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12398.html The U.S. Food and Drug Administration approved Nexium (esomeprazole magnesium) for short-term use in children ages 1-11 years for the treatment of gastroesophageal reflux disease (GERD). The agency approved Nexium in two forms, a delayed-release capsule and liquid form. Nexium is approved in 10 milligrams (mg) or 20 mg daily for children 1-11 years old compared to 20 mg or 40 mg recommended for pediatric patients 12 to 17 years of age. This approval provides important information for appropriate dosing for children ages 1-11 years with GERD, said Julie Beitz, M.D., director of the FDA's Office of Drug Evaluation III in the Center for Drug Evaluation and Research. Children prescribed this drug should be monitored by their physicians for any adverse drug reactions. http://www.compliancehome.com/news/FDA/12398.html Mon, 10 Mar 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12397.html The U.S. Food and Drug Administration today issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs). Some of these products, directed at U.S. consumers, falsely claim to have FDA Approval and some claim to be more effective than conventional medicine. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products. http://www.compliancehome.com/news/FDA/12397.html Mon, 25 Feb 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12322.html Siemens Healthcare's Versant 440 Molecular System has been approved for marketing by the U.S. Food and Drug Administration (FDA) for use with the Versant HCV RNA 3.0 assay for management of HCV-infected patients undergoing antiviral therapy. The Versant 440 Molecular System represents the next generation in automated viral load testing, providing laboratories with greater throughput and less hands-on time, maximizing productivity to meet the evolving needs of the clinical laboratory. http://www.compliancehome.com/news/FDA/12322.html Mon, 25 Feb 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12321.html SuperVision Entertainment announced that the FDA recently approved an artificial sweetener made from all-natural crops such as wheat, rice, corn, potatoes, barley etc. It is a radical departure from such artificial sweeteners such as Aspartame, Splenda and others that are basically chemical cocktails of one form or another. This amazing new product is produced by creating an enzymatic degradation of all the natural crops which is then processed and purified. The end result is an all-natural sweetener that looks exactly like honey, tastes exactly like honey, and has the same consistency as honey. In fact, it's putting bees out of business. The product is FDA approved for inclusion in literally thousands of products from cereals, chocolate bars, colas, nutrition bars, baking goods and hundreds of other classifications of foods. In short, anywhere sugar is used, this product can be used to replace sugar. http://www.compliancehome.com/news/FDA/12321.html Mon, 25 Feb 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12320.html Roche announced that Genentech has received U.S. Food and Drug Administration (FDA) accelerated approval for Avastin (bevacizumab), in combination with paclitaxel chemotherapy, for the first-line treatment of patients with locally recurrent or metastatic breast cancer. The approval is based on a phase III study (E2100) which showed that for patients with metastatic breast cancer the addition of Avastin to paclitaxel compared to paclitaxel alone doubled the chance of being alive without the disease advancing (progression-free survival). In Europe Avastin received full approval for the treatment of metastatic breast cancer in March 2007. http://www.compliancehome.com/news/FDA/12320.html Mon, 25 Feb 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12317.html Pyng Medical announced the Company has received Special 510(K) regulatory clearance from the US Food and Drug Administration to market its new and improved version of the award-winning FAST1 Intraosseous (IO) Infusion System throughout the US, effective immediately. FAST1 is the most rapid, reliable and safe alternative to conventional IV infusion providing lifesaving vascular access for fluid and drug resuscitation in shock and trauma victims. The Company's lead clinical product has been re-engineered with a superior infusion tube that no longer requires the use of a removal tool. The product shipped to all non-FDA jurisdictions during the fourth quarter of 2007 and now begins shipment into the US. http://www.compliancehome.com/news/FDA/12317.html Mon, 25 Feb 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12316.html SoftLight Development unveiled its new Web-based teleradiology study management service, called Telerad, at the HIMSS exhibition in Orlando. Telerad enables teleradiologists to access their studies over the Web from any computer, while maintaining HIPAA compliance, and keeps both stationary images and animations in an FDA-compliant Dicom format, so accurate measurements can be taken as though the doctor were actually in the office with the patient. Telerad supports all radiology modality types, including MRI, CT, sonogram, PET scan and others, and supports cinefeatures in multiple modalities. Like the majority of SoftLights products, it is downloadable, installing in a day or less, and is paid for on a transactional basis clinics and teleradiologists can download Telerad for free and pay a small fee each time information is transferred from the clinic to the teleradiologist or vice versa. http://www.compliancehome.com/news/FDA/12316.html Thu, 21 Feb 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12303.html MetricStream announced a new release of its Compliance Management application. The new release is designed to manage compliance with multiple regulations across complex organizational structures through a common framework. As the multiple compliance initiatives become more intertwined from regulatory and organizational perspectives, Compliance Officers are focusing on effective rationalization of controls to provide a clear, unambiguous process for compliance management and to deliver a single point of reference for the organization. The new release of the Compliance Management application provides a configurable framework to document processes, risks and controls across multiple areas of compliance including cross-industry mandates and regulations such as SOX, OSHA, EH&S and FCPA as well as the industry focused regulatory guidelines from FDA, NASD, FERC, PCI, FAA, HACCP, AML, Basel II and data retention laws. The documentation can be applied across a hierarchical organization structur http://www.compliancehome.com/news/FDA/12303.html Tue, 19 Feb 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12291.html Alter-G, developers of the G-Trainer anti-gravity treadmill, announced that the FDA has cleared the company for marketing the G-Trainer as a medical device. The G-Trainer is applicable for medical uses in rehabilitation after lower extremity injury or surgery, aerobic conditioning, weight control, gait training for neurological conditions, and strengthening and conditioning for older patients. In addition, during 2007 the G-Trainer has already seen overwhelming adoption as a training and conditioning tool that also reduces the risk of impact-related injuries while exercising. I believe the G-Trainer will become the standard in rehabilitation and training, said Dr. Amol Saxena, podiatric surgeon at the Palo Alto Medical Foundation. Dr. Saxena is an internationally known podiatric surgeon who has conducted research on chronic ankle pain, Achilles and peroneal tendons, stress fractures, midfoot injuries, and arthritis of the first metatarsal phalangeal joint and has authored dozens of art http://www.compliancehome.com/news/FDA/12291.html Mon, 18 Feb 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12285.html The U.S. Food and Drug Administration (FDA) today issued draft guidance on Good Reprint Practices for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices. Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care, said Randall Lutter, FDA deputy commissioner for policy. This guidance also safeguards against off-label promotion. http://www.compliancehome.com/news/FDA/12285.html Wed, 30 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12189.html Lumension Security, a global security management company formed by the combination of PatchLink Corporation and SecureWave S.A., today announced the introduction of PatchLink Security Configuration Management, the industry's first enterprise-class solution that ensures secure and compliant endpoint configurations in accordance with industry best practices. PatchLink SCM leverages the Security Content Automation Protocol (SCAP) and is seamlessly integrated into Lumension Security's proven, market-leading solutions, PatchLink Scan and PatchLink Update. The PatchLink SCM solution provides both commercial and government entities with out-of-the box regulatory and best-practices templates to ensure all of their systems and applications are properly configured. http://www.compliancehome.com/news/FDA/12189.html Wed, 30 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12188.html Escalon Medical announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the VascuView Visual Ultrasound System for use with assisted vascular access. Its subsidiary, Escalon Vascular Access, Inc., plans to commence shipments of the product in the United States immediately. We are excited to announce the FDA clearance and introduction of the new VascuView Visual Ultrasound System, said Michael O'Donnell, President of Escalon Vascular Access. Developed with doctors and clinicians ultrasound needs in mind, the VascuView system couples unparalleled portability with a large image display and intuitive touchscreen operation which allow users to focus on the task at hand. Whether mounted on a stand, used table top bedside, or fit into a carrying case for field use, the VascuView is highly adaptable to the challenges of varying departmental environments within a hospital. http://www.compliancehome.com/news/FDA/12188.html Tue, 29 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12177.html Edwards Lifesciences Corporation announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) for a revised design to the U.S. pivotal clinical trial of the Edwards SAPIEN transcatheter aortic heart valve technology. The FDA approved the addition of the Ascendra transapical delivery system to the trial, and also granted permission to Edwards to increase its trial sample size from 600 patients to 1,040 patients. The PARTNER (Placement of AoRTic traNscathetER valves) trial, initiated in the second quarter of 2007, is evaluating the Edwards SAPIEN valve in patients who are considered high risk or inoperable for conventional open-heart valve surgery. http://www.compliancehome.com/news/FDA/12177.html Thu, 24 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12148.html inal plans are taking shape for the 18th annual Association for the Advancement of Medical Instrumentation (AAMI)/FDA International Conference on Medical Device Standards and Regulation (ISC), which will include sessions on medical device connectors and misconnections; the role of standards in the global medical device supply chains; and emerging standards issues in Asia, Europe, and the Americas. The conference which will be held March 1920 in the Washington, DC area is designed for professionals who are responsible for complying with, or understanding, medical device standards and regulations. http://www.compliancehome.com/news/FDA/12148.html Wed, 23 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12138.html The Food and Drug Administration has launched a misguided attack on estriol despite overwhelming evidence it is safe and effective for women in menopause, according to Erika Schwartz MD at www.DrErika.com. Why would the FDA try to take estriol off the market when it is not only safe for women in menopause, it may even help women with multiple sclerosis, writes Dr. Erika. Maybe it is because the agency is more concerned with protecting Wyeth than it is with protecting women, she says. http://www.compliancehome.com/news/FDA/12138.html Tue, 22 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12133.html St. Jude Medical, announced U.S. Food and Drug Administration (FDA) approval of software and firmware updates to the Merlin.net Patient Care Network (PCN). The new Merlin.net PCN 2.5 will expand availability of the system nationwide and provide physicians with improved options for remotely monitoring their patients with the most commonly-used St. Jude Medical implantable cardiac devices. The upgraded system includes enhancements to the Housecall Plus transmitter which patients use to convey data from their devices over phone lines to the central Merlin.net PCN data repository. The new modifications offer improved ease of use for patients and physicians, a simple, one-step procedure for data transmission, expansion of services to include the entire U.S., and the ability to accommodate patients with devices who travel out of the U.S. by allowing them to transmit data from overseas. http://www.compliancehome.com/news/FDA/12133.html Tue, 22 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12128.html Nycomed announced that the Food and Drug Administration (FDA) approved ALVESCO (ciclesonide) Inhalation Aerosol in the United States for the maintenance treatment of asthma and as prophylactic therapy in adult and adolescent patients aged 12 years and older. ALVESCO is an inhaled corticosteroid with novel release and distribution properties. Commercialisation and marketing of ALVESCO will be achieved through a U.S. commercial partner. The decision of the FDA allows the product to be sold in the largest pharmaceutical market in the world, where it is patent protected until 2017. Nycomed is in active negotiations with possible marketing partners for the commercialisation of ALVESCO in the United States. The outlicensing strategy in the U.S. is consistent with Nycomed's direction to seek marketing and commercialisation partnerships for the Nycomed's assets in the U.S. market. http://www.compliancehome.com/news/FDA/12128.html Tue, 22 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12127.html The U.S. Food and Drug Administration today approved the first clotting solution manufactured using recombinant DNA techniques to help stop small blood vessels from bleeding after surgery. The new solution, called Recothrom, is a topical thrombin solution. Thrombin is a protein involved in the production of fibrin, a different protein necessary for blood to clot. Recombinant DNA is the result of a genetic modification process that enables scientists to create new DNA strands with specific traits, such as the capacity to produce a specific protein. http://www.compliancehome.com/news/FDA/12127.html Tue, 22 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12126.html The U.S. Food and Drug Administration has cleared for marketing a test that simultaneously detects four common respiratory viruses, including the flu, in a patients respiratory secretions. The ProFlu+ test provides results in as few as three hours. Other diagnostic tests for respiratory viruses are fast but not as accurate or are accurate but not as rapid. The real-time test employs a multiplex platform that allows several tests to be processed using the same sample to detect influenza A virus, influenza B virus, and respiratory syncytial virus A and B (RSV). http://www.compliancehome.com/news/FDA/12126.html Tue, 22 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12125.html The U.S. Food and Drug Administration (FDA) today approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism. The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for VTE. http://www.compliancehome.com/news/FDA/12125.html Tue, 22 Jan 2008 00:00:00 CST http://www.compliancehome.com/news/FDA/12124.html The U.S. Food and Drug Administration (FDA) announced that New Era Canning Company, New Era, Mich., is expanding its product recall because of potential Clostridium botulinum (C. botulinum) contamination to all canned green beans and garbanzo beans distributed by the company nationwide over the last five years. C. botulinum can cause botulism, a serious and sometimes life-threatening condition. The affected cans are large institutional-sized containers, weighing approximately six and a half pounds. Symptoms of botulism poisoning in humans can begin from 6 hours to 2 weeks after eating food that contains the toxin. Symptoms may include double vision, blurred vision, drooping eyelids, slurred speech, difficulty swallowing, and muscle weakness that moves progressively down the body, affecting the shoulders first, then descending to the upper arms, lower arms, thighs, and calves. Botulism poisoning also can cause paralysis of the breathing muscles, which can result in death unless assistan http://www.compliancehome.com/news/FDA/12124.html