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 Wed, 07 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13691.html The Food and Drug Administration, the US regulator, is to unveil a pioneering mechanism this year that rewards pharmaceutical companies for their research into previously neglected diseases with vouchers for accelerated drug reviews. These vouchers highly valuable as they might speed up market access for new medicines can then be sold on to other companies, which can use them for any drug. The FDA is planning the launch of the priority review vouchers (PRVs) in August. The vouchers are designed to stimulate research into tropical diseases, for which there is little commercial market. http://www.compliancehome.com/resources/FDA/Articles/abstract13691.html Wed, 07 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13690.html Discovery Laboratories Inc. said Monday that it received an approvable letter from the Food and Drug Administration for Surfaxin, its treatment for the prevention of respiratory distress syndrome in premature infants, and that it could file a response with the FDA in six to eight weeks. The company said it believes the steps required to file a response to the approvable letter may be completed within that time and that the response may potentially be designated by the FDA as a class one resubmission with a review target of 60 days. http://www.compliancehome.com/resources/FDA/Articles/abstract13690.html Mon, 05 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13689.html It was a frank answer to a blunt question about the Food and Drug Administration's ability to protect America's food supply.Rep. John Dingell, D-Mich., chairman of the House Energy and Commerce Committee, ticked off an FDA advisory panel's recent findings that food inspections in America had declined by 78 percent since the 1970s _ even as imports surged. http://www.compliancehome.com/resources/FDA/Articles/abstract13689.html Mon, 05 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13688.html Insulin pumps are used by tens of thousands of teenagers worldwide with Type 1 diabetes, but they can be risky and have been linked to injuries and even deaths, a review by federal regulators finds. Parents should be vigilant in watching their children's use of the pumps, researchers from the Food and Drug Administration wrote. They didn't advise against using the devices. But they called for more study to address safety concerns in teens and even younger children who use the popular pumps. The federal review of use by young people over a decade found 13 deaths and more than 1,500 injuries connected with the pumps. At times, the devices malfunctioned, but other times, teens were careless or took risks, the study authors wrote. http://www.compliancehome.com/resources/FDA/Articles/abstract13688.html Mon, 05 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13687.html As laws are being drafted to regulate the sale of alternative medicine, consumers are being warned against buying drugs off the Internet for personal use. http://www.compliancehome.com/resources/FDA/Articles/abstract13687.html Mon, 05 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13686.html The US Food and Drug Administration (FDA) has sent Merck & Co a warning letter saying it has failed to correct a number of manufacturing deficiencies at its main vaccine manufacturing plant in West Point, Pennsylvania. The agency said Merck had filed an 'inadequate response http://www.compliancehome.com/resources/FDA/Articles/abstract13686.html Fri, 02 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13673.html The U.S. Food and Drug Administration's final analysis of certain flavors of http://www.compliancehome.com/resources/FDA/Articles/abstract13673.html Fri, 02 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13662.html The U.S. Food and Drug Administration aims to hire more than 1,300 biologists, chemists, pharmacologists and other staff members by October as part of a major expansion, the agency said on Wednesday. The hiring effort, first reported by Reuters, comes as the agency is under growing pressure from Congress to improve operations and existing staff is stretched thin. The new hires will add to the current FDA work force of more than 10,000 employees who regulate food, drugs and other products that account for a quarter of U.S. consumer spending. http://www.compliancehome.com/resources/FDA/Articles/abstract13662.html Fri, 02 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13661.html Federal drug regulators believe that a contaminant detected in a crucial blood thinner that has caused 81 deaths was added deliberately, something the Food and Drug Administration has only hinted at previously. F.D.A.s working hypothesis is that this was intentional contamination, but this is not yet proven, Dr. Janet Woodcock, director of the Food and Drug Administrations drug center, told the House Subcommittee on Oversight and Investigations in written testimony given Tuesday. A third of the material in some batches of the thinner heparin were contaminants, and it does strain ones credulity to suggest that might have been done accidentally, Dr. Woodcock said. http://www.compliancehome.com/resources/FDA/Articles/abstract13661.html Fri, 02 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13660.html Following a recent publication in this paper regarding 12 logging companies been barred by the Forestry Development Authority (FDA), additional 5 logging companies have been added to the list by the Concession review Committee. The five include: Cavalla Timber, Exotic Timber Corporation Enterprise incorporated and Nature Liberia Incorporated. Others include: Salami Mohammed Incorporated and Timber Management Corporation. It can be recalled that the twelve logging companies' bar was imposed when it was discovered that they operated outside of the threshold behavior criteria and were found to have been overtly involved in at least one of the following actions: support to militia, participated in, or facilitation of, arms for timber, or otherwise aided or abated civil instability. http://www.compliancehome.com/resources/FDA/Articles/abstract13660.html Fri, 02 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13659.html The government is evaluating a new version of OxyContin the potent painkiller sometimes called http://www.compliancehome.com/resources/FDA/Articles/abstract13659.html Fri, 02 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13658.html The Food and Drug Administration approved for marketing AngioScore Inc.'s balloon catheter device, the company said Thursday. Fremont-based AngioScore, which develops angioplasty catheters for use in the treatment of cardiovascular disease, said the FDA cleared the device for balloon dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter received initial FDA 510(k) clearance for the treatment of infra-popliteal peripheral arterial disease in September 2005. http://www.compliancehome.com/resources/FDA/Articles/abstract13658.html Fri, 02 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13657.html Democrats seeking to boost funding for the U.S. Food and Drug Administration found support Thursday from a key federal employees union. The president of the National Treasury Employees Union, which represents 150, 000 federal employees, said the recent move by a bipartisan group of senators urging their budget panel colleagues to hike FDA funding shows http://www.compliancehome.com/resources/FDA/Articles/abstract13657.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13633.html Artificial blood raised death risks by 30 percent and almost tripled the odds of heart attacks in 16 clinical trials analyzed by researchers who say U.S. regulators should have stopped the studies eight years ago. Five trials involving substitute blood products are ongoing, and a new one is about to begin, the researchers reported. The Food and Drug Administration is holding a workshop in Bethesda, Maryland, tomorrow to discuss safety of the products. The researchers, in a report in the Journal of the American Medical Association, said the FDA in 2000 received data on individual studies showing increased risks that should have triggered suspension of testing until a large-scale analysis. Now the agency should end all trials and Congress should review rules forcing the FDA to keep information on new products confidential for competitive reasons, the researchers said. http://www.compliancehome.com/resources/FDA/Articles/abstract13633.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13632.html Medtronic's Physio-Control subsidiary, which makes external defibrillators but stopped U.S. shipments in January 2007 because of quality problems, is facing an extended stoppage from lingering issues found by the Food and Drug Administration. An FDA complaint filed in U.S. District Court noted that the agency inspected Physio-Control's Redmond, Wash., plant again from Jan. 2 to Feb. 6 and found continued problems. The FDA said: http://www.compliancehome.com/resources/FDA/Articles/abstract13632.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13631.html A new analysis concludes that the Food and Drug Administration approved experiments with artificial blood substitutes even after studies showed that the controversial products posed a clear risk of causing heart attacks and death. The review of combined data from more than 3,711 patients who participated in 16 studies testing five different types of artificial blood, released yesterday, found that the products nearly tripled the risk of heart attacks and boosted the chances of dying by 30 percent. http://www.compliancehome.com/resources/FDA/Articles/abstract13631.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13630.html A U.S. Food and Drug Administration panel says the agency should require enhanced warnings about the risks associated with LASIK eye surgery, an increasingly popular procedure to correct vision. The group, which has been studying the issue for a year, says the surgery has a very high success rate, indicating that more than 95 percent of patients have expressed satisfaction with the results. Its study was prompted by the 140 patients who have written letters of complaints to the FDA. http://www.compliancehome.com/resources/FDA/Articles/abstract13630.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13629.html MediQuest Therapeutics said Monday that it requested approval by federal regulators of its experimental therapy to treat Raynaud's disease. The U.S. Food and Drug Administration must accept the submission before it reviews the drug's effectiveness. Even if the FDA agrees to study the therapy a topical solution that relieves the painful ailment that constricts blood flow to the extremities the approval process could take several months. The submission, however, puts the closely held Bothell pharmaceutical company in the small club of Seattle-area companies that have filed a new drug application with the FDA. Others include ZymoGenetics, Immunex, Dendreon and Icos. http://www.compliancehome.com/resources/FDA/Articles/abstract13629.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13620.html Ever since the National Toxicology Program said two weeks ago that bisphenol A (BPA), a widely used compound in hard plastic food containers, poses http://www.compliancehome.com/resources/FDA/Articles/abstract13620.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13619.html A new analysis concludes that the Food and Drug Administration approved experiments with artificial blood substitutes even after studies showed that the controversial products posed a clear risk of causing heart attacks and death. The review of combined data from more than 3,711 patients who participated in 16 studies testing five different types of artificial blood, released yesterday, found that the products nearly tripled the risk of heart attacks and boosted the chances of dying by 30 percent. Based on the findings, the researchers questioned why the FDA allowed additional testing of the products to go forward and why the agency is considering letting yet another study proceed. http://www.compliancehome.com/resources/FDA/Articles/abstract13619.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13610.html emocrats in Congress and the Food and Drug Administration are in a standoff over giving the agency $70 million to bolster foreign drug inspections, which have come under fire amid deaths linked to tainted blood-thinning drugs from China. Members of Congress have blasted the FDA for lapses in inspections of Chinese drug factories since contaminated heparin from China has been linked to as many as 81 deaths. http://www.compliancehome.com/resources/FDA/Articles/abstract13610.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13609.html Golf great Tiger Woods lauds vision-correcting LASIK surgery as http://www.compliancehome.com/resources/FDA/Articles/abstract13609.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13599.html In response to complaints of double vision, blurry vision and other complications following popular laser surgery to improve eyesight, the Food and Drug Administration is looking for ways to better educate patients about the possible risks and to assess the scope of the problems, an official said yesterday. http://www.compliancehome.com/resources/FDA/Articles/abstract13599.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13598.html Allow litigation, but make it hard to win cases against drugmakers. When the Food and Drug Administration approves a new drug as safe and effective, that isn't always the end of the story. Sometimes, after the drug has been widely marketed, adverse effects start to appear. The most notorious recent example is Vioxx, the painkiller that went from new blockbuster medicine in 1999 to off the market in 2004, after studies showed a significantly higher risk of heart attack and stroke in certain patients. Such cases raise provocative questions: Should victims of drugs gone bad be able to sue and collect from the makers of the drug? Or should the FDA's seal of approval shield the pharmaceutical companies from litigation? If the drugs' makers and the Bush administration get their way in a case pending at the U.S. Supreme Court, the FDA's endorsement of a medicine or a warning label could be enough to bar lawsuits. And in a perfect world, that's how it should be. The FDA would be able to police http://www.compliancehome.com/resources/FDA/Articles/abstract13598.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13597.html Rare side effects reported with laser eye-correcting surgery will get a closer look from the Food and Drug Administration Friday. Millions of Americans have undergone Lasik surgery to improve their eyesight since FDA first approved lasers for the procedure a decade ago. But since then, the agency has received more than 140 reports of problems with the procedure. Lasik side effects include blurred vision, dry eyes and halos around lights when seen at night. FDA will also ask its panel of eye experts to consider these issues Friday and whether patients need to be given more information before deciding to undergo surgery. The panel will also comment on a proposed study looking at patients' expectations of Lasik surgery. http://www.compliancehome.com/resources/FDA/Articles/abstract13597.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13585.html Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators, according to data released today. The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun, according to the FDA. To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after medications come to market. The research is usually voluntary, and lawmakers have repeatedly complained it isn't completed. President George W. Bush signed legislation in September that allows the FDA to require certain post-approval studies. http://www.compliancehome.com/resources/FDA/Articles/abstract13585.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13584.html The Food and Drug Administration on Wednesday granted Shire approval to market its attention-deficit hyperactivity drug Vyvanse to adults. The drug was approved last year to treat ADHD in children ages 6 to 12. http://www.compliancehome.com/resources/FDA/Articles/abstract13584.html Thu, 01 May 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13583.html U.S. makers of pet food and all other animal feed will be prevented from using certain materials from cattle at the greatest risk for spreading mad cow disease under a rule that regulators finalized on Wednesday. The U.S. Food and Drug Administration, which oversees animal feed, said excluding high-risk materials from cattle 30 months of age or older from all animal feed will prevent any accidental cross-contamination between ruminant feed (intended for animals such as cattle) and non-ruminant feed or feed ingredients. http://www.compliancehome.com/resources/FDA/Articles/abstract13583.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13577.html How crucial is Europe to the global pharmaceutical market? First consider that Europe, North America, and Japan comprise 80 percent of the world's pharmaceutical market. Take that statistic in conjunction with the estimation from Report Buyer, a renowned market research firm, that the Western European market alone is expected to grow to $245.3 billion by 2012. The engine that drives the European pharmaceutical market machine is, without question, the European Union (EU). With 27 member states, the EU represents the bulk of the European market. The 10 individual European markets that joined the EU in 2004 continue to show strong growth and contribute to the EU pharmaceutical market's overall strength. Pharmaceutical companies searching for further success in Europe or those wanting to capitalize on these strong growth trends by entering the European market for the first time must efficiently and cost-effectively obtain and maintain marketing authorization (MA). While individual member s http://www.compliancehome.com/resources/FDA/Articles/abstract13577.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13576.html The US Food and Drug Administration (FDA) has revealed evidence linking the heparin contaminant with the series of reported adverse reactions, and has also now issued a warning letter to the Chinese facility at the centre of the safety scare after completing its inspection. In a media briefing, director of the FDA's CDER Janet Woodcock said that the agency has both in vitro and animal data displaying a http://www.compliancehome.com/resources/FDA/Articles/abstract13576.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13575.html The U.S. Food and Drug Administration plans to seek advice from a panel of outside experts over whether to provide more information to patients about laser eye surgery, according to documents released on Wednesday. The FDA's comments come ahead of a public meeting set for Friday to discuss patient satisfaction with the LASIK procedure that some analysts said could cloud an industry already pinched by weakening demand amid a slowing U.S. economy. http://www.compliancehome.com/resources/FDA/Articles/abstract13575.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13574.html Under the cloud of contaminated heparin deaths, Food and Drug Administration Commissioner Andrew von Eschenbach received a rude welcome from Congress Tuesday, accused by Rep. John Dingell, D-Mich., of http://www.compliancehome.com/resources/FDA/Articles/abstract13574.html Thu, 24 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13573.html The Food and Drug Administration will unveil this week a federal rule that will place new restrictions on what U.S. livestock can be fed. The primary objective is to reduce the risk of transmitting bovine spongiform encephalopathy, or mad-cow disease, among cattle, but it is also expected to help persuade foreign countries to remove import restrictions on U.S. beef, according to a pre-publishing copy of the document. South Korea last week agreed to lift restrictions on U.S. beef and, according to one U.S. government official, the country did so on the condition that the U.S. strengthen its livestock feed rules. The U.S. discovered its first case of BSE in December 2003, and has since reported two other cases. http://www.compliancehome.com/resources/FDA/Articles/abstract13573.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13563.html The head of the U.S. Food and Drug Administration, commissioner Dr. Andrew C. von Eschenbach took quite a beating to say the least as he was grilled by the House Energy and Commerce Committee for the lack of drug oversight by the FDA. This comes as the fallout of the tainted heparin continues, among other major lapses. Dr. Andrew C. von Eschenbach stated that the FDA has simply does not have the budget to be able to keep up with all of the inspections as needed. http://www.compliancehome.com/resources/FDA/Articles/abstract13563.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13556.html House members chastised the Food and Drug Administration on Tuesday for not doing more inspections of foreign drug manufacturers in the wake of a litany of problems with the blood thinner heparin and other products. http://www.compliancehome.com/resources/FDA/Articles/abstract13556.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13555.html The U.S. Food and Drug Administration has warned Zila Pharmaceuticals Inc about promoting its Peridex oral rinse without including information about possible risks, according to a letter released on Tuesday. A mailed promotional piece for the rinse, which is approved to treat gingivitis, also made unproven claims about how well Peridex worked and made false statements about competitors' products, the FDA wrote in an April 18 letter to Zila Pharmaceuticals, a unit of Zila Inc. http://www.compliancehome.com/resources/FDA/Articles/abstract13555.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13554.html Andrew von Eschenbach, the commissioner of the U.S. Food and Drug Administration, isn't doing his job and hasn't asked for enough money to inspect overseas drugmakers, a senior lawmaker said today at a hearing. Representative John D. Dingell, a Democrat from Michigan who is chairman of the House Energy and Commerce Committee, pointed his finger at von Eschenbach and repeatedly asked the FDA chief how much it would cost to do more inspections. Dingell objected when the commissioner didn't provide specifics. Dingell and other lawmakers said the FDA must conduct more inspections of companies sending drugs to the U.S. to ensure they are safe. Lawmakers cited deaths and allergic reactions linked to contaminated versions of the blood-thinner heparin from China and described other tainted products, including toothpaste, that were shipped to the U.S. http://www.compliancehome.com/resources/FDA/Articles/abstract13554.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13553.html The Food and Drug Administration (FDA) will limit the distribution of diet pills by state hospitals and private clinics following the suicide of a bank employee. Officials suspect she was suffering from depression caused by misuse of diet pills. FDA secretary general Chatree Banchuen yesterday said doctors will control the distribution of diet pills to patients. State hospitals will be allowed to stock no more than six months' supply and private clinics no more than three months'. State and private clinics will be able to buy only 5,000 units per month of each type of diet pill. The medicines include phentermine, diazepam, thyroxin, propranolol, diuretics, laxatives, amphepramone, d-norpseudoephedrine, fenfluramine and thyroid hormones. Of these, phentermine seems the most popular despite the fact that a medical prescription is required for its sale. http://www.compliancehome.com/resources/FDA/Articles/abstract13553.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13551.html In a case coming before the Supreme Court this fall, the justices will decide whether the Food and Drug Administration's approval of a drug preempts private lawsuits by consumers who suffer adverse effects from the drug -- or, put another way, whether FDA. approval insulates drug manufacturers from such lawsuits. A decision in favor of the defendant, Wyeth Pharmaceuticals, would have profound impact. For the more than 70 years of the FDA's existence, the agency's drug approval process has been supplemented by the separate and equally necessary layer of protection provided by private litigation. A finding of preemption would essentially remove that long-established layer of protection. As a cascade of recent examples demonstrates, FDA approval does not and cannot warrant a drug's safety over its lifetime. Vioxx, Celebrex, Halcion, Paxil, the weight loss pill ephedra -- the list goes on. In each of these cases, private litigation exposed risks the FDA did not foresee -- and, importantly, http://www.compliancehome.com/resources/FDA/Articles/abstract13551.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13542.html The U.S. Food and Drug Administration Monday approved a new type of heart-pumping device from Thoratec Corp. designed to support heart patients who are awaiting transplants. The FDA approved Thoratec's HeartMate II device, which is a smaller version of the company's HeartMate XVE that is already on the market. The product is designed for heart-failure patients who are awaiting heart transplants. The device is implanted in the chest in order to help the heart's lower left chamber pump blood throughout the body. The device is powered by a battery that is worn outside the body. Because the HeartMate II device is smaller than the older generation HeartMate device, it can be used in patients of smaller body size, including many women who were ineligible to receive larger heart-pumping devices. http://www.compliancehome.com/resources/FDA/Articles/abstract13542.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13541.html Federal regulators have warned Pfizer Inc. for not mentioning the risks of Viagra in an advertisement featuring country musicians singing the praises of its popular impotency pill. The Food and Drug Administration called on Pfizer to discontinue the online video advertisement in a warning letter issued last week and posted online Monday. The 30-second video, which appeared on CNN.com, showed a group of Nashville musicians singing the refrain http://www.compliancehome.com/resources/FDA/Articles/abstract13541.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13540.html China and the United States traded charges Monday about whether a contaminant in the blood thinner heparin caused severe allergic reactions linked to as many as 81 deaths. Federal health officials said new tests indicated a solid link. China said the contaminant could not be the http://www.compliancehome.com/resources/FDA/Articles/abstract13540.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13539.html After holding a dozen investigatory hearings into the actions, or, more accurately, the lack of action, by the Food and Drug Administration, congressional committees have laid out the skeleton of major changes it wants the agency to institute to insure the safety of imported food, drugs and medical devices. http://www.compliancehome.com/resources/FDA/Articles/abstract13539.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13538.html An online advertisement with men praising Viagra to the tune of an Elvis Presley song has drawn objections from U.S. regulators, who said drugmaker Pfizer Inc failed to list the impotence drug's risks.Pfizer said the omission of side effects warnings was due to a technical error on CNN's Web site, www.cnn.com, which ran the advertisement. The Food and Drug Administration sent a written warning to Pfizer that was made public on Monday. http://www.compliancehome.com/resources/FDA/Articles/abstract13538.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13537.html Contaminated heparin products have now been found in at least nine countries, not including the United States, leading to ongoing surveillance measures to ensure the safety of the blood thinner, U.S. health officials announced Monday. In addition, officials said contaminated lots of the blood thinner have been traced to 12 different Chinese companies that were somehow involved in heparin manufacture. Officials believe a man-made chemical called oversulfated condroitin sulfate -- or OSCS -- may be responsible for dozens of deaths and hundreds of adverse reactions in the United States associated with contaminated heparin between roughly last November and February. The heparin was marketed by Baxter International Inc., of Deerfield, Ill. http://www.compliancehome.com/resources/FDA/Articles/abstract13537.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13535.html In an April press release, the FDA issued a consumer alerts after high levels of selenium were found in some Total Body Formula and Total Body Mega Formula products. The products are flavored dietary supplements by Total Body Essential Nutrition of Atlanta. The FDA warns that consumers should not use the Tropical Orange and Peach Nectar ( the Total Body Formula) or the Orange/Tangerine flavor (the Total Body Mega Formula) due to the unsafe selenium levels. http://www.compliancehome.com/resources/FDA/Articles/abstract13535.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13531.html The U.S. has fairly rigorous standards for approving drugs, but its ability to find side effects after drugs are on the market is kind of laughable. Essentially, the agency has to count on having doctors voluntarily report side effects to catch ones that make it through clinical trials unnoticed. These side effects often go unreported because it's not clear that they're even side effects of one of the medications the patient is taking. But not anymore. The FDA is teaming up with health insurer WellPoint (NYSE: WLP) to use the company's vast database of 35 million members' medical records to try teasing out the real side effects from all the unrelated ones. Wellpoint's Safety Sentinel System would have been more aptly named Safety Ordinal System (SOS) -- since it's certainly coming to the FDA's rescue. http://www.compliancehome.com/resources/FDA/Articles/abstract13531.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13530.html New fees for food and drug companies anchor draft legislation released Thursday that's aimed at improving the safety of the nation's food and drug supply. The draft legislation, spearheaded by Rep. John Dingell, D-Mich., and other Democratic leaders of a powerful House committee, also says regulators should inspect food and drug makers more frequently. The proposal, if enacted, would lead to major changes in food and drug oversight, and it was quick to draw rebukes. http://www.compliancehome.com/resources/FDA/Articles/abstract13530.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13529.html The Food and Drug Administration has increasingly come under fire for not doing its job. In the past four years, the agency that regulates about 20 percent of the U.S. economy has been criticized for exposing patients to medicines that do more harm than good, letting contaminated imports get into the country and failing to protect the food supply. Dr. Andrew von Eschenbach, an oncologist and cancer survivor who was appointed head of the FDA in 2006, was in the Triangle on Thursday to talk about initiatives started on his watch to treat the ills of the agency. http://www.compliancehome.com/resources/FDA/Articles/abstract13529.html Wed, 23 Apr 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract13514.html The pharmaceutical industry glimpsed its own ghost this week, and the apparition could not have arrived at a worse time for drug makers. A report indicating that Merck used ghostwriters to produce medical journal articles in support of its subsequently discredited drug Vioxx has galvanized opponents to a federal proposal that would relax some restrictions on drug promotion. The Food and Drug Administration has been considering a proposal to let drug makers use reprints of journal articles in promoting drugs for so-called off-label uses the F.D.A. itself has not approved. A main proviso of the proposal is that the articles must have been published in peer-reviewed medical journals. http://www.compliancehome.com/resources/FDA/Articles/abstract13514.html