http://www.compliancehome.com/ ComplianceHome is one of the Web's largest library of resources for compliance management of HIPAA, SOX, FISMA, GLBA, FDA, 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 Fri, 18 Jun 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18987.html The U.S. Food and Drug Administration is called by a U.S. senator to reveal findings about a possible link between a chemical found in most sunscreens and skin cancer. The agency has been reviewing data from several studies on a potential connection between retinyl palmitate, a common sunscreen additive, and cases of skin cancer since July but has yet to issue any rulings or guidelines, said Sen. Charles E. Schumer (D-N.Y.). http://www.compliancehome.com/resources/FDA/Articles/abstract18987.html Fri, 18 Jun 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18984.html An investigations is on by the U.S. Food and Drug Administration if Daiichi Sankyo's (4568.T) blood pressure medicine Benicar increases the risk of heart-related death, although the agency said it still believes the benefits of the drug outweigh its potential risks. The FDA said it is evaluating data from a pair of clinical trials in which diabetes patients taking the drug, known chemically as olmesartan, had a higher rate of death from heart related causes compared with patients taking a placebo. http://www.compliancehome.com/resources/FDA/Articles/abstract18984.html Fri, 18 Jun 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18983.html A Food and Drug Administration advisory panel unanimously recommended approval of the first drug for multiple sclerosis (MS) that can be taken orally. Existing drugs for the disease have to be given intravenously or by injection. The new drug, targeted initially at relapsing-remitting MS, is called fingolimod and its manufacturer, Novartis, plans to use the brand name Gilenia. The agency is not required to follow the recommendations of its advisory panels, but it generally does. http://www.compliancehome.com/resources/FDA/Articles/abstract18983.html Fri, 18 Jun 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18969.html FDA issued a 12-page warning letter to Pfizer Chief Executive Jeffrey Kindler and cited the numerous examples involving some of the company's top-known brands, including impotence drug Viagra, cholesterol pill Lipitor and seizure medicine Lyrica. The delays in reporting side effects date back as far as 2004 and have grown in recent years, according to the FDA's letter that was released by Pfizer http://www.compliancehome.com/resources/FDA/Articles/abstract18969.html Fri, 18 Jun 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18964.html FDA Issues Global Raw Packaged Seafood Import Alert: FDAImports.com Reports Numerous International Firms Impacted Detention Without Physical Examination of Refrigerated Vacuum Pak or Modified Atmosphere Packaged Raw Fish and Fishery Product, or Import Alert #16-25, is currently impacting exporters around the world who regularly ship modified atmosphere or vacuum packed, raw seafood into the US. According to this law, the FDA will detain all imported, raw seafood by default, provided that these items have been shipped by firms which do not meet requirements set forth by a 'Green List' used by the FDA. The FDA created this alert in order to stave off cases of Clostridium Botulinum, or deadly botulism poisoning. This becomes a risk when uncooked seafood is sent in packaging which does not allow anaerobic conditions in which oxygen can circulate. As of September of 2009, the FDA's Green List only lists 46 international firms that meet the standards set forth by IA #16-125. http://www.compliancehome.com/resources/FDA/Articles/abstract18964.html Fri, 18 Jun 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18952.html FDA has issued the approval of slight changes to the labeling of the weight loss drug Xenical. The label will now include information about the very rare instances of liver injury that have been noted with thirteen cases. The FDA did point out that this labeling change did not mean that the use of Xenical had been the cause of the liver injury but in line with established practice and following the recent review of Xenical they felt it would be prudent to do so http://www.compliancehome.com/resources/FDA/Articles/abstract18952.html Fri, 18 Jun 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18951.html A voluntary recall by Blacksmith Brands for four kinds of PediaCare children's products has been announced by the U.S. Food and Drug Administration. The agency notified health-care professionals and patients about a nationwide recall of all lots of four PediaCare medicines, sold exclusively in the United States and manufactured by McNeil Consumer Healthcare in Pennsylvania. http://www.compliancehome.com/resources/FDA/Articles/abstract18951.html Tue, 25 May 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18940.html FDA Tobacco Products Scientific Advisory Committee will meet to discuss dissolvable tobacco products and menthol cigarettes ahead of required reports to the Secretary of Health and Human Services regarding the public health impact of these products. Tobacco industry presentations on menthol in cigarettes will include the following: the characterization of menthol, the clinical effects of menthol, the bio-markers of disease risk, industry marketing data, and the population effects of menthol cigarettes. http://www.compliancehome.com/resources/FDA/Articles/abstract18940.html Tue, 25 May 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18939.html A latest treatment for advanced prostate cancer gets consent from FDA. The FDA has approved Provenge, a cellular immunotherapy drug. It is the first drug approved by the FDA in its class. Provenge works by stimulating the bodys own immune system to attack the cancer. Skin cancer is the most common form of cancer amoung men in the U.S and prostate cancer is the second most common form. The National Cancer Institute reports that in 2009 approximately 27,000 men died from prostate cancer and 192,000 new cases were reported http://www.compliancehome.com/resources/FDA/Articles/abstract18939.html Fri, 21 May 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18921.html Natazia, a creation of the labs of Bayer HealthCare Pharmaceuticals lately gets an approval from FDA. This is not the initial offering of the product though, as it has been available in Europe, but under the different name of Qlaira. In facts released by the FDA regarding studies done about this new drug, research showed that 1800 plus women were given the product and it was found to be effective in preventing unwanted pregnancy. Whats more, it also provided other data that will be very important to those that decide to take it. http://www.compliancehome.com/resources/FDA/Articles/abstract18921.html Fri, 21 May 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18920.html Israeli biopharmaceutical company Kamada Inc declares that it expects to receive U.S. Food and Drug Administration approval for its treatment of Alpha-1 Antitrypsin deficiency (AATD) in early July. The company said the FDA's examination of its biological licence application is expected to be completed in the second quarter. Its shares were up 10.6 percent at 20.79 shekels in afternoon trade in Tel Aviv. The FDA has approved the use of the name Glassia for the intravenous drug, which treats the genetic disorder AATD, Kamada said in a statement. http://www.compliancehome.com/resources/FDA/Articles/abstract18920.html Wed, 21 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18899.html The Food and Drug Administration is calling for greater oversight of medical devices for home use, as hospitals discharge patients after ever-shorter stays and more people continue post-operative care or treat chronic conditions with sophisticated medical equipment at home. http://www.compliancehome.com/resources/FDA/Articles/abstract18899.html Wed, 21 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18898.html The US Food and Drug Administration (FDA) launched a new Web site allowing people to track how the agency has regulated a catheter or a computed tomography (CT) scanner from the approval process, to reports of errors or adverse events once the device is on the market, to a product recall. http://www.compliancehome.com/resources/FDA/Articles/abstract18898.html Wed, 21 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18895.html The Food and Drug Administration published guidance for small egg producers to help them comply with a 2009 federal egg safety regulation designed to prevent Salmonella Enteritidis in shell eggs during production, transportation, and storage on April 13, http://www.compliancehome.com/resources/FDA/Articles/abstract18895.html Wed, 21 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18894.html Strides Arcolab Ltd said it has received US FDA approval for mesna injection, an abbreviated new drug application (ANDA). Mesna injections are used to reduce the incidence of hemorrhagic cystitis caused by chemotherapy, the company said in a statement to the stock exchange. The US market for mesna injections is about USD12 million annually and the product would be launched soon in partnership with Sagent Pharmaceuticals, it said. http://www.compliancehome.com/resources/FDA/Articles/abstract18894.html Wed, 21 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18892.html Shares of Boston Scientific gained ground in early trading , the morning after the medical-device maker's announcement that the U.S. Food and Drug Administration has cleared the company to resume sales of two of its leading products. http://www.compliancehome.com/resources/FDA/Articles/abstract18892.html Wed, 21 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18891.html Hospira Inc. (HSP) disclosed it recently received a warning letter from the Food and Drug Administration related to plants where it makes already-recalled dietary supplement and anesthesia products that had issues with metal particles. The products in question are called Liposyn and Propofol, which Hospira voluntary pulled from the market in November. http://www.compliancehome.com/resources/FDA/Articles/abstract18891.html Tue, 13 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18882.html Johnson & Johnson's (JNJ.N) Pancreaze, a pancreatic enzyme product used to improve food digestion in patients whose bodies do not produce enough of the enzymes gets an approval from the U.S. Food and Drug Administration http://www.compliancehome.com/resources/FDA/Articles/abstract18882.html Tue, 13 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18881.html Mylan Inc. received Food and Drug Administration approval to sell a generic version of Merck and Co.'s blood pressure pill Hyzaar. The drug had U.S. sales in 2009 of about $695 million, Mylan said. Teva Pharmaceutical Industries Ltd. said last week it also received FDA approval to start selling generic versions of Hyzaar and another Merck blood pressure drug, Cozaar. http://www.compliancehome.com/resources/FDA/Articles/abstract18881.html Tue, 13 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18876.html The US Food and Drug Administration (FDA) in its latest effort to reduce the risks of medical radiation, notified manufacturers of radiotherapy equipment such as linear accelerators that they can no longer count on winning approval for their products through the speedy, streamlined review processes previously available to them. http://www.compliancehome.com/resources/FDA/Articles/abstract18876.html Tue, 13 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18875.html Painkillers and anti-inflammatory drugs have been ingested by more in an attempt to deal with the severe pain of herniated discs, sciatica, bulging discs, degenerative disc disease, etc. Back surgery has been used as a last resort to handle this type of pain, and many have just learned to live with it. http://www.compliancehome.com/resources/FDA/Articles/abstract18875.html Fri, 09 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18866.html Federal regulators have cited Biogen Idec, Inc. for attempting to downplay the risks of a rare, but often fatal, brain infection that has been linked to the multiple sclerosis drug Tysabri. The FDA sent a warning letter (pdf) to the company on March 25, accusing the company of misleading statements made in a series of webcasts used to promote Tysabri. According to the FDA, Biogen aired the webcast eight times between late October and early November of 2009. http://www.compliancehome.com/resources/FDA/Articles/abstract18866.html Fri, 09 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18865.html The Food and Drug Administration said that it was taking steps to reduce overdoses, underdoses and other errors in radiation therapy by strengthening the agencys approval process for new radiotherapy equipment. http://www.compliancehome.com/resources/FDA/Articles/abstract18865.html Fri, 09 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18862.html The US Food and Drug Administration will begin requiring device manufacturers to provide information in certain premarket applications regarding pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use. The new rule stems from the 2007 FDA Amendments Act. Very few devices are developed or assessed specifically for use in pediatric patients, those 21 or younger at the time of treatment or diagnosis. This effort will provide a better understanding of which devices developed for use in adults should be assessed or modified for use in pediatric populations, according to an FDA press release on the rule, which will also help the agency track approved devices that could benefit pediatric patients. http://www.compliancehome.com/resources/FDA/Articles/abstract18862.html Fri, 09 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18861.html Teva Pharmaceutical Industries Ltd. said received Food and Drug Administration approval to start selling generic versions of Merck and Co.'s blockbuster blood pressure drugs Cozaar and Hyzaar. The move will mark a big hit to Merck's revenue, as the two drugs together are Merck's second-highest revenue generator. In 2009, global sales of Cozaar and Hyzaar totaled $3.6 billion. http://www.compliancehome.com/resources/FDA/Articles/abstract18861.html Fri, 09 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18850.html The U.S. Food and Drug Administration approved TachoSil, a patch that's used to stop bleeding during heart surgery and can be absorbed by the body. The protein-coated patch is made from horse tendons and can be used when traditional surgical procedures can't -- or won't -- stop mild-to-moderate bleeding. http://www.compliancehome.com/resources/FDA/Articles/abstract18850.html Fri, 09 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18849.html A reformulated version of the powerful painkiller OxyContin that is designed to make it harder to tamper with the product gets an approval from the Food and Drug Administration. OxyContin was first approved by the FDA in 1995 to treat severe chronic pain and was designed to be swallowed whole and digested over 12 hours. http://www.compliancehome.com/resources/FDA/Articles/abstract18849.html Fri, 09 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18835.html Federal officials began grappling with one of the thorniest issues surrounding the regulation of tobacco: whether to ban menthol, the most popular cigarette flavoring, which is smoked by millions of Americans every day. http://www.compliancehome.com/resources/FDA/Articles/abstract18835.html Fri, 09 Apr 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18834.html Each year nearly 70 million CT scans are performed in the U.S. But now, government scientists say the FDA has ignored warnings about the radiation risk. Radiologists say a 10-minute virtual colonoscopy can detect colon polyps 90 percent of the time. But are they worth the risk of exposure to radiation? http://www.compliancehome.com/resources/FDA/Articles/abstract18834.html Wed, 31 Mar 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18831.html Consumers have been warned by the FDA and several Midwestern state health agencies haveagainst drinking unpasteurized, raw milk following an outbreak of campylobacteriosis. About 12 confirmed reports of raw milk related illness was reported on March 24 to the Michigan Department of Community Health, the FDA reported in its announcement of the alert. http://www.compliancehome.com/resources/FDA/Articles/abstract18831.html Wed, 31 Mar 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18830.html U.S. District Court Judge Richard Arcara dropped a permanent injunction on Jerald Schumacher of Wyoming, N.Y., ordering him to stop offering animals for slaughter until he complies with federal law regarding drug and antibiotic withdrawal periods. Schumacher, according to U.S. Food and Drug Administration records, has repeatedly sold animals at the Pavilion (N.Y.) livestock auction to be slaughtered for human consumption over at least 10 years. According to the FDA complaint, a number of those animals tested positive for penicillin and sulfadimethoxine residues. The agency also said he illegally gave the cows extra-label (higher than allowed) dosages. The farmer also violated federal law by failing to keep adequate records of which cows were medicated, according to the complaint. http://www.compliancehome.com/resources/FDA/Articles/abstract18830.html Wed, 31 Mar 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18824.html U.S. regulators approved the use of Salix Pharmaceuticals Ltd's Xifaxan antibiotic as a treatment for reducing the risk of a debilitating liver disorder in adults. The company's shares rose about 7 percent. The Food and Drug Administration approved the drug for reducing the risk of recurrent hepatic encephalopathy, a disorder caused by chronic liver failure that can cause confusion, memory problems or coma. http://www.compliancehome.com/resources/FDA/Articles/abstract18824.html Tue, 23 Mar 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18814.html A warning for patients who take high doses of the drug Zocor has been issued by FDA. Zocor is a drug that is prescribed to patients who suffer from high cholesterol . The drug was issued a warning because it can cause muscle injury which can lead to Rhabdomyolysis. This can lead to kidney disease, renal failure, and in some instances can prove fatal. http://www.compliancehome.com/resources/FDA/Articles/abstract18814.html Fri, 26 Feb 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18771.html The Food and Drug Administration gives its consent to a new pneumococcal vaccine that protects against more strains of bacteria than the existing one and is expected to produce a sharp reduction in the number of cases of bacterial pneumonia and ear infections in children and adolescents. http://www.compliancehome.com/resources/FDA/Articles/abstract18771.html Wed, 24 Feb 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18758.html U.S. Food and Drug Administrations (FDA) has granted its approval for Norvir, a new tablet formulation of its anti-retroviral medication. The tablets that do not require refrigeration and can be stored at room temperature; come in the form of soft-gelatin capsules, which contain 100 mg of ritonavir. As well, they can also be used in combination with other anti-retroviral HIV medications. http://www.compliancehome.com/resources/FDA/Articles/abstract18758.html Wed, 24 Feb 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18757.html U.S. Food and Drug Administration (FDA) has approved the hypertension treatment Benicar(R) (olmesartan medoxomil) for use in children and adolescents 6 to 16 years of age, announced by Daiichi Sankyo, Inc. Benicar was originally approved in 2002 for the treatment of hypertension in adults. Approximately 5 percent - or 3.6 million - American children suffer from high blood pressure, with the majority unaware they have the condition.(4)(5) Studies have also found that the average blood pressure of American children is on the rise, in parallel with the increase of children's weight.(6) In fact, an analysis of nearly 40 years of national surveys of high blood pressure trends in children and adolescents showed that the prevalence of elevated blood pressure among this group has been growing since the late 1980's.(7) http://www.compliancehome.com/resources/FDA/Articles/abstract18757.html Sun, 14 Feb 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18755.html The federal Food and Drug Administration said that it would take steps to more stringently regulate three of the most potent forms of medical radiation, including increasingly popular CT scans, some of which deliver the radiation equivalent of 400 chest X-rays. http://www.compliancehome.com/resources/FDA/Articles/abstract18755.html Sun, 14 Feb 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18750.html Generic drugmaker Teva Pharmaceutical Industries Ltd said the U.S. Food and Drug Administration will review its application to sell a biotechnology medicine to boost white blood cells that is similar to Amgen Inc's big-selling Neupogen. Teva said the FDA accepted its Biologics License Application for the medicine for which it has proposed the trade name Neutroval. The Teva drug, XM02, is already being sold under the name TevaGrastim in several European countries, where a pathway for approving generic versions of biotech drugs -- so-called biosimilars -- is already in place. http://www.compliancehome.com/resources/FDA/Articles/abstract18750.html Sun, 14 Feb 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18749.html The U.S. Food and Drug Administration on Tuesday approved Auxilium Pharmaceuticals Inc.'s Xiaflex injection to treat a hand disease that causes http://www.compliancehome.com/resources/FDA/Articles/abstract18749.html Thu, 14 Jan 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18710.html U.S. Marshals last week seized more than $1 million worth of food from a company that supplies restaurants throughout Tennessee. The agency was acting on the request of the Food and Drug Administration, which cited the company, Won Feng Trading Company, for distributing food from a rodent-infested facility in Nashville http://www.compliancehome.com/resources/FDA/Articles/abstract18710.html Thu, 14 Jan 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18709.html The U.S. Food and Drug Administration has approved Actemra, a potential blockbuster, to treat a type of rheumatoid arthritis. However, the Basel-based drug company didn't garner a much hoped-for first-line nod http://www.compliancehome.com/resources/FDA/Articles/abstract18709.html Mon, 11 Jan 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18701.html The Food and Drug Administration said Wednesday that it would review of the safety of the widely used anemia drugs sold by Amgen and Johnson & Johnson after another clinical trial suggested that high doses of one of the drugs might cause strokes. http://www.compliancehome.com/resources/FDA/Articles/abstract18701.html Sun, 03 Jan 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18684.html The U.S. Food and Drug Administration (FDA) has approved the marketing of ZOLL Medical Corporation's E series defibrillators equipped with carbon monoxide (CO) monitoring. The new model of the ZOLL E series monitor/defibrillator is available for shipment with immediate effect. http://www.compliancehome.com/resources/FDA/Articles/abstract18684.html Sun, 03 Jan 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18683.html The US Food and Drug Association (FDA) has come under fire once again this week. Two independent studies were published that are critical of the agency's approval process for medical devices. These findings may prove to have long lasting effects in the US justice system. A court case decided in 2008, Riegel versus Medtronic, concluded that approval from the FDA grants companies that produce medical devices free and clear of lawsuits resulting in injuries from their products. http://www.compliancehome.com/resources/FDA/Articles/abstract18683.html Sun, 03 Jan 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18679.html Research that included a review of 80 cardiac devices shows that FDA approval of the devices followed a single study. The findings suggest that high quality studies are needed prior to pre-market approval (PMA) of cardiac devices that include pacemakers, implantable cardiac defibrillators and stents. http://www.compliancehome.com/resources/FDA/Articles/abstract18679.html Sun, 03 Jan 2010 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18678.html According to Pfizer Inc. the U.S. Food and Drug Administration would continue its review of a new version of the children's vaccine Prevnar past its previous deadline. http://www.compliancehome.com/resources/FDA/Articles/abstract18678.html Tue, 29 Dec 2009 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18658.html According to the Food and Drug Administration (FDA) Nestle is guilty of misleading consumers when it comes to some of their drink products for children. According to the agency, the company made misleading claims pertaining to nutrient values in some of their popular childrens drinks, not good indeed for the credibility of Nestle. http://www.compliancehome.com/resources/FDA/Articles/abstract18658.html Tue, 29 Dec 2009 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18651.html The FDA says an Oregon company is recalling 114,350 pounds of shelled hazelnuts that have http://www.compliancehome.com/resources/FDA/Articles/abstract18651.html Tue, 29 Dec 2009 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18650.html Arena Pharmaceuticals has applied to the Food and Drug Administration for approval of a weight-loss drug, putting it ahead of two potential competitors with drugs in the works. The San Diego company had said in September that it believed its latest data was strong enough for an FDA approval that would enable it to start marketing the drug, lorcaserin. Since then, it has been working to get the application in by years end. The company said 47.2 percent of patients on a twice-daily dose of the drug lost at least 5 percent of their weight. The average person in that group lost 5.9 percent of their weight, or 13 pounds for the average, 220-pound patient in the study. http://www.compliancehome.com/resources/FDA/Articles/abstract18650.html Thu, 17 Dec 2009 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract18606.html A widget that can help distribute user-friendly public-health information has been launched by The U.S. Food and Drug Administration. For the non-techies among you, a widget is a small cluster of computer code -- an application, really -- that can be copied onto Web pages. Widgets come in many shapes and with many functions, but this one will basically allow bloggers or pet stores to feature constantly up-to-date information supplied by the FDA on their own site http://www.compliancehome.com/resources/FDA/Articles/abstract18606.html