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 Thu, 24 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14604.html The Bush administration would strongly oppose a bill that would give the FDA the power to regulate tobacco, according to a letter Health and Human Services Secretary Mike Leavitt sent to House Republican Joe Barton. The Associated Press reported on the letter yesterday.The bill which takes on a subject thats been batted around for years in Washington has a lot of support in Congress. Its co-sponsored by 56 Senators (including both Obama and McCain) and 233 members of the House. It cleared a key House committee by a vote of 38-12 earlier this year, with the support of 11 Republicans. And, in part because the bill would prohibit the FDA from outlawing tobacco or banning nicotine, Philip Morris USA (part of Altria) is supporting the legislation, the AP notes. http://www.compliancehome.com/resources/FDA/Articles/abstract14604.html Thu, 24 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14593.html We've all become accustomed to seeing http://www.compliancehome.com/resources/FDA/Articles/abstract14593.html Thu, 24 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14592.html Two leading U.S. Democrats said on Tuesday they are investigating the Food and Drug Administration's approval of drugs sold by India's Ranbaxy. Reps. John Dingell and Bart Stupak said in a statement they are probing whether the FDA http://www.compliancehome.com/resources/FDA/Articles/abstract14592.html Thu, 24 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14586.html Cell Therapeutics which markets lymphoma drug Zevalin in the U.S., said Tuesday that it has scheduled a meeting with the U.S. Food and Drug Administration, or FDA, in September. In the meeting, the biotechnology company will talk about the possibility of filing a supplemental Biologics License Application, or sBLA, for using Zevalin as a consolidation therapy after remission induction in previously untreated patients with follicular non-Hodgkin's lymphoma, or NHL. The Seattle, Washington-based company noted that the basis for the filing would be data taken from the First-line Indolent Trial of Bayer Schering Pharma (BSGP.L). Cell Therapeutics recently gained access to the study results through an agreement with Bayer Schering. http://www.compliancehome.com/resources/FDA/Articles/abstract14586.html Thu, 24 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14579.html Government inspectors have found the same salmonella strain responsible for a nationwide food-poisoning outbreak in a Mexican-grown jalapeno in a Texas plant, prompting a new warning for consumers to avoid eating fresh jalapenos. The Food and Drug Administration called Monday's announcement a http://www.compliancehome.com/resources/FDA/Articles/abstract14579.html Mon, 21 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14558.html For two and a half years, the Food and Drug Administration collected evidence that Ranbaxy Laboratories, India's largest generic drugmaker, may have lied about the quality of medicines and chemicals it sent to the U.S. Regulators inspected Ranbaxy plants in India, subpoenaed records, visited warehouses in Uganda and Nigeria, and FBI agents raided the company's offices in Plainsboro and plant in New Brunswick. This month, federal prosecutors said in court papers that the drugmaker's http://www.compliancehome.com/resources/FDA/Articles/abstract14558.html Mon, 21 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14557.html Under fire from some United States (US) senators for allegedly taking lenient positions in granting product approvals to generic companies from countries like India, the US FDA is planning to speed up its plans to set up offices in India by 2009. FDA, in its latest newsletter dated July 21, has said that the agency will set up offices in Mumbai and Delhi to intensify its monitoring efforts. The offices are part of the authority's FDA With Borders Initiative announced few months ago. http://www.compliancehome.com/resources/FDA/Articles/abstract14557.html Mon, 21 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14556.html An FDA advisory panel has recommended that warning labels for the flu drug Tamiflu be amended to emphasize that the reported side effects might also occur in flu patients who are not taking the drug. After reports of nearly 600 psychiatric side effects since the drug's introduction in 1999, the FDA asked an advisory panel to review whether the warning label on Tamiflu should be strengthened. The use of Tamiflu has been heaviest in Japan, where there have been reports of at least 14 deaths due to neuropsychiatric symptoms among flu patients taking the drug. According to the FDA, five children under the age of 17 died after http://www.compliancehome.com/resources/FDA/Articles/abstract14556.html Mon, 21 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14555.html There are limits on free speech. Hollering fire in a crowded theater is perhaps the better known one. There should be another. Take the tomato industry, or what is left of it in Florida. Everyone wants the Centers for Disease Control and the Food and Drug Administration to keep us healthy and protect our food supply. However, after a few hundred cases of the Salmonella Saintpaul virus, the agencies scripted a horror plot one could call http://www.compliancehome.com/resources/FDA/Articles/abstract14555.html Mon, 21 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14554.html Despite the cloud of disquiet facing the Indian generic pharma industry over recent allegations by US Food and Drug Administration (FDA) regarding Ranbaxy's drug adulteration charge, US FDA is keen to identify areas of collaboration between the two countries. The apex body for drugs in US has already initiated the talks with India to help evolve the common norms to ensure its citizens' safety. US FDA monitors, regulates and gives the permission for drugs. At a recent meeting in San Diego, USA, the idea of capacity building through partnerships of the manpower and infrastructure were thoroughly discussed between the representatives of the Indian government as well as officials of US FDA. US FDA is keen to help the Indian regulatory infrastructure. http://www.compliancehome.com/resources/FDA/Articles/abstract14554.html Mon, 21 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14548.html The Food and Drug Administration has unveiled a plan for recruiting young staffers to replace the hundreds of scientists retiring from the agency. The FDA said Thursday it will launch a two-year fellowship program for physicians, chemists, statisticians and other science professionals interested in food and drug regulation. About 30 to 40 fellows will be accepted for the first program, which begins in October. Some of those accepted are expected to stay on as full-time employees after completing the program, which includes course work and seminars. Congress has been pressuring the agency, which employs 10,100 staffers, to improve its operations, strengthen its inspections and hire more experts. The average age of the FDA's work force is 54, and about 30 percent of general staffers already are eligible to retire. The agency is working to replace more than 700 employees by October. http://www.compliancehome.com/resources/FDA/Articles/abstract14548.html Mon, 21 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14547.html In a blow to fresh veggie-avoiding kids across the land, the Food and Drug Administration has declared that raw tomatoes are again safe to eat. The innocent-looking vegetable turned sinister in April, when it was connected to the first of a nationwide wave of salmonella infections. Since then, over 1,200 people in 42 states have contracted the gastrointestinally discomfiting bug, and jalapeno and serrano peppers have also been fingered as culprits. Tons of (digital) ink were spilled over the outbreak, but this is its first feature appearance in Wired Science. (The outbreak did prompt the Bush administration to cough up a few FDA-improving bucks in June.) Quite frankly, what's the big deal? From the reports -- almost invariably headlined by salmonella's http://www.compliancehome.com/resources/FDA/Articles/abstract14547.html Mon, 21 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14546.html Two US Congress members have expressed doubts over the quality of inspections conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities. Congressmen John Dingell and Bart Stupak have said the ongoing FDA-Ranbaxy row over alleged supply of http://www.compliancehome.com/resources/FDA/Articles/abstract14546.html Mon, 21 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14537.html The US drug regulator FDA, which has charged Ranbaxy with selling unsafe medicines in the country, has come under the Congress scanner and will be probed for its conduct in approving the Indian pharma major's products and other potential violations in the matter. A Congressional Committee has said that it would examine Ranbaxy's drug approvals in the US and potential violations of manufacturing regulations, a media report said. Besides, the House Energy and Commerce Committee would also http://www.compliancehome.com/resources/FDA/Articles/abstract14537.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14522.html How, exactly, did Wal-Mart become the new Food and Drug Administration? The giant retailer, along with CVS (CVS, Fortune 500) and Toys 'R Us, announced recently that it plans to stop selling baby bottles containing the chemical bisphenol-A. The question is, why? Bisphenol-A has been widely used since the 1950s. The Food and Drug Administration, as well as Japanese and European regulators, have no problems with it. Canada is about to ban it from baby bottles, but officials term the move purely precautionary. To be sure, other scientists worry because animal studies have linked small doses of BPA to cancer and other health problems. But scientific debate isn't driving the baby bottle war; a hard-hitting push by activist groups, politicians and trial lawyers is. http://www.compliancehome.com/resources/FDA/Articles/abstract14522.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14521.html In its first meeting in a year, on July 15 the FDA Orthopaedic and Rehabilitation Devices Panel voted 5-2 against recommending the premarket approval application for a spinal anti-adhesion gel intended for use in patients undergoing lumbar spine surgery. Oxiplex S/P Gel, a tissue barrier product (FzioMed Inc., San Luis Obispo, Calif.), is approved for use in 49 countries, including Canada. It has been used in about 100,000 procedures worldwide, company officials said. http://www.compliancehome.com/resources/FDA/Articles/abstract14521.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14520.html The recent batch of warning letters issued by the FDA once again causes me to worry about eating anything. One in particular FDA warning letter dated 7/2/08 to Chief Operating Officer at Full Circle Dairy in Lee, FL proves the FDA is so after the fact it is a wonder we all arent sick. The FDA warning letter to Full Circle Dairy was dated 7/2/08 the inspection of this dairy farm took place on 2/6/08 and 2/11/08 five months earlier. Worse yet, the warning letter reprimanded Full Circle Dairy for selling medicated animals processed in human food in June 2007 and August 2007. A warning letter was mailed five months AFTER the incident was discovered and one year after the incident had occurred! Your tax dollars at work. Per the warning letter http://www.compliancehome.com/resources/FDA/Articles/abstract14520.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14519.html A panel of government experts on Wednesday said studies from Johnson & Johnson are not strong enough to justify approval of its antibiotic to treat pneumonia. A Food and Drug Administration panel of antibiotic experts voted 9-4 against accepting studies J&J submitted to support its application to market Doribax for hospital-acquired pneumonia, which is often more virulent than other strains. The group's recommendations are non-binding, though the FDA often follows its advice. http://www.compliancehome.com/resources/FDA/Articles/abstract14519.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14513.html U.S. drug reviewers have http://www.compliancehome.com/resources/FDA/Articles/abstract14513.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14512.html The Food and Drug Administration is warning doctors and patients that electronic devices such as pacemakers, cardiac defibrillators and insulin pumps can malfunction when people get computed tomography (CT) scans. The popular scans can cause medical devices to shock patients or start sending inaccurate signals, the FDA said in a public health alert issued Monday afternoon. The agency has received six confirmed reports of devices that malfunctioned after a CT scan and another nine reports of suspected problems, FDA spokeswoman Karen Riley said. No deaths occurred. Also, a study published last year by researchers at the Mayo Clinic found that CT scans frequently interfered with electronic heart devices, although the impact was temporary. http://www.compliancehome.com/resources/FDA/Articles/abstract14512.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14511.html In Indiana, nearly 11,400 children a year become regular smokers. In our state alone, we spend more than $2 billion on health-care costs directly caused by smoking; and 9,800 people die from tobacco each year -- the leading cause of preventable death and disease in Indiana. They're not just statistics. They're our moms and dads, our brothers and sisters, our grandmas and grandpas, our friends and the people we work with. They are members of the congregations that Indiana's people of faith lead. These are real people that tobacco has taken from us. Advertisement The best way to reduce tobacco-related deaths is to prevent kids from starting to smoke. That's because 90 percent of all smokers start by age 18 or younger. Tobacco companies know their future depends on their ability to recruit new, young smokers. http://www.compliancehome.com/resources/FDA/Articles/abstract14511.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14510.html Medical device maker St. Jude Medical Inc. said Tuesday federal regulators approved a wireless technology to help doctors keep an eye on patients with implanted heart devices. The system, called Merlin.net Patient Network, automatically sends information from pacemakers and other heart devices to a secure online database, where it can be reviewed online by doctors. Prior device-monitoring systems required patients to send information manually using a telephone line, but St. Jude said the new system works http://www.compliancehome.com/resources/FDA/Articles/abstract14510.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14506.html U.S. health officials have announced plans for a new computer tracking system that has been designed to help identify specific dangers stemming from prescription drugs and medical devices that are currently on the market. This system would enable the Food and Drug Administration (FDA) to search certain databases for possible evidence of side effects. These databases include, but are not limited to, the government's Medicare health insurance plan. The new system is called the Sentinel System, and it is designed to better track risks that may emerge from more widespread use of products in the marketplace. http://www.compliancehome.com/resources/FDA/Articles/abstract14506.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14505.html The United States Food and Drug Administration today refused to comment on a motion filed by the Department of Justice in a US District Court in Maryland against Indian drug major Ranbaxy Pharmaceuticals. http://www.compliancehome.com/resources/FDA/Articles/abstract14505.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14504.html The Food and Drug Administration is warning doctors and patients that electronic devices such as pacemakers, cardiac defibrillators and insulin pumps can malfunction when people get computerized tomography (CT) scans. The popular scans can cause medical devices to shock patients or start sending inaccurate signals, the FDA said in a public health alert issued Monday afternoon.The agency has received six confirmed reports of devices that malfunctioned after a CT scan and another nine reports of suspected problems, FDA spokeswoman Karen Riley said. No deaths occurred.Also, a study published last year by researchers at the Mayo Clinic found that CT scans frequently interfered with electronic heart devices, although the impact was temporary. http://www.compliancehome.com/resources/FDA/Articles/abstract14504.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14503.html In Indiana, nearly 11,400 children a year become regular smokers. In our state alone, we spend more than $2 billion on health-care costs directly caused by smoking; and 9,800 people die from tobacco each year -- the leading cause of preventable death and disease in Indiana. They're not just statistics. They're our moms and dads, our brothers and sisters, our grandmas and grandpas, our friends and the people we work with. They are members of the congregations that Indiana's people of faith lead. These are real people that tobacco has taken from us. Advertisement The best way to reduce tobacco-related deaths is to prevent kids from starting to smoke. That's because 90 percent of all smokers start by age 18 or younger. Tobacco companies know their future depends on their ability to recruit new, young smokers. http://www.compliancehome.com/resources/FDA/Articles/abstract14503.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14502.html The US Food and Drug Administration (FDA) is continuing to evolve in the face of current challenges through the launch of two new initiatives. Firstly the agency has called time on its http://www.compliancehome.com/resources/FDA/Articles/abstract14502.html Thu, 17 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14494.html A Johnson & Johnson antibiotic appears to be safe, government regulators said Monday, but its effectiveness in fighting pneumonia is up for debate this week. J&J has asked the Food and Drug Administration to approve its drug Doribax to treat hospital-acquired pneumonia, which is often more virulent than other strains. On Wednesday the FDA will seek input on the drug's safety and effectiveness from a panel of outside experts. While J&J's studies of the drug showed few serious side effects, FDA scientists said it is more difficult to judge whether Doribax treats pneumonia more effectively than older antibiotics. http://www.compliancehome.com/resources/FDA/Articles/abstract14494.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14487.html After my recent blog posting ( http://www.compliancehome.com/resources/FDA/Articles/abstract14487.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14484.html The jokes about Attack of the Killer Tomatoes are wearing as thin as the plot to that 1978 cult classic. The tomato farmers, who are facing financial disaster, arent laughing as their tomatoes lie rotting in the fields or are being plowed under. The Food and Drug Administration, according to Asoociated Press writer Garance Burke, still is not sure what the source is that has caused the salmonella outbreak. The tomato is suspect, but the FDA cannot verify the origin of the contamination. Now the government has a doubt as to whether it was tomatoes after they already blackened our eye, Paul DiMare, the president of the DiMare Companies, is quoted in the article. The Center for Disease Controls website states that more than 1,000 people have been infected with the Salmonella Saintpaul bacterium between April and June of this year. Only 6 people were infected with that particular strain of salmonella during the same period in 2007. About a third of the cases are in Texas 381 accord http://www.compliancehome.com/resources/FDA/Articles/abstract14484.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14483.html The United States Food and Drugs Administration has filed a complaint against Indian drugmaker Ranbaxy Laboratories Ltd with a local court, saying that the quality of drugs made at one of its domestic plants is poor, according to a person familiar with the matter. Ranbaxy, however, defended itself saying the court has not initiated any proceedings against the company. Ranbaxy strongly denies these allegations contained in the motion, said a company spokesperson. A motion has been filed, but not granted, with FDA seeking certain documents from Ranbaxy, the spokesperson said. No legal proceedings have been initiated against Ranbaxy, said the spokesperson. We continue to cooperate with the US Department of Justice and we continue to remain committed to providing high-quality generics to the US markets and patients, he said. http://www.compliancehome.com/resources/FDA/Articles/abstract14483.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14482.html The U.S.Food and Drug Administration (FDA) issued a letter to the manufacturers of certain antibiotics to request that a Boxed Warning in the product labeling be printed to highlight the increased risk of tendinitis and tendon rupture among patients taking these medications. The affected antibiotics include Bayer AG's Cipro and Avelox, Oscient Pharmaceuticals Corp's Factive, Depomed Inc's Proquin XR, Johnson & Johnson's Levaquin and Floxin and Merck & Co Inc's Noroxin. The generic form of Cipro, ciprofloxacin and the generic form of Floxin, ofloxaci are also affected. These drugs belong to a class known as fluoroquinolones. The request was based on the agencys new authority under the Food and Drug Administration Amendments Act of 2007 and the FDA action was triggered by its findings that these drugs have some serious safety issues that patients and doctors need to know. http://www.compliancehome.com/resources/FDA/Articles/abstract14482.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14481.html A new device that allows patients to communicate with their doctors, get information about their health status, and find out about their condition has received clearance from United States Food and Drug Administration. Intel, the world's largest semi-conductor company, has received approval for its health management tool - The Intel Health Guide. According to Med Headlines, the device allows doctors to monitor their patient's statistics via e-mail and videoconferencing. The tool connects to certain models of wired and wireless devices such as blood pressure monitors, glucose meters, pulse oximeters and peak flow meters. http://www.compliancehome.com/resources/FDA/Articles/abstract14481.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14479.html The Food and Drug Administration has established a pilot program and draft guidance for drug companies to voluntarily submit registration information and their list of pharmaceutical products in an electronic format, the agency said in a draft guidance published today in the Federal Register. The requested information is fundamental to many processes the agency uses for surveillance for serious drug reactions, inspection of facilities used for drug manufacturing and processing, and monitoring imported drug products inspection, the FDA said. Submitting the information electronically and in a standard approach will modernize the FDA's processes and improve its timeliness and accuracy, said Jeffrey Shuren, the agency's associate commissioner for policy and planning, said in the posting. http://www.compliancehome.com/resources/FDA/Articles/abstract14479.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14478.html LegalView, the number one resource for everything legal on the Internet, reported details of a recent U.S. Food and Drug Administration (FDA) mandate regarding the fluoroquinolones antibiotics family of drugs. All of the fluoroquinolones will now carry black box warning labels to ensure physicians and patients understand that the drugs have been associated with an increased risk of tendonitis and tendon rupture. Among the most common of the fluoroquinolone antibiotics are Levaquin, Cipro, Factive and Avelox - some of the most commonly prescribed anti-bacterial drugs. Levaquin, also known as levofloxacin, is an antibiotic that fights infections including bronchitis, pneumonia, Chlamydia, gonorrhea, skin infections, urinary tract infections, etc. It has been previously linked to Achilles tendonitis among patients who were prescribed the drug. A study released in The Journal of American Board of Family Medicine reported the Levaquin warning and associated risks with prescribing the drug, http://www.compliancehome.com/resources/FDA/Articles/abstract14478.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14473.html Advisers to the U.S. Food and Drug Administration on Thursday opposed a stepped-up warning about suicide risks from epilepsy drugs, including Abbott Laboratories' Depakote, saying a heightened alert might cause people to shun treatment they need. The FDA advisory panel agreed with the agency's staff that the drugs, taken by millions of Americans, boost the danger of suicidal thoughts and actions. But the advisers then rejected a proposal to require the medicines to carry the agency's strictest caution, a so-called black-box warning, because such a prominent caution might do more harm than good, they said. http://www.compliancehome.com/resources/FDA/Articles/abstract14473.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14472.html Until yesterday, the FDA had been rolling steadily toward slapping a black-box warning on epilepsy drugs because they may increase the risk of suicidal thoughts and behaviors. But a committee of outside experts convened by the FDA thinks thats a bad idea. The panel voted 14-4 against the black-box warning yesterday, with three abstentions, the WSJ reports. The committee members did agree that some risk may be associated with the drugs. But the panel didnt seem to think that the risk, which the FDA found by pooling data from many studies, is high enough to merit a black-box the most serious warning commonly used for prescription drugs. Among the medicines reviewed were Pfizers Lyrica, Abbott Laboratories Depakote and Johnson & Johnsons Topamax. http://www.compliancehome.com/resources/FDA/Articles/abstract14472.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14471.html A month after warning consumers against eating certain types of tomatoes that may be contaminated with Salmonella, the federal government now is warning against eating raw jalapeno or serrano peppers. The U.S. Food and Drug Administration added the hot pepper varieties on Wednesday to its continued nationwide warning about an outbreak of the Saintpaul type of Salmonella. Since April, 408 Texans have been sickened with the disease, eight of those in Fort Bend County, according to the Texas Department of Health. The updated government warning came several days after the Baltimore Sun reported that Maryland health officials believed jalapeno peppers could play a part in the outbreak. Last month, grocers cleared their shelves of roma and large round tomatoes after the FDA warned they could be contaminated. http://www.compliancehome.com/resources/FDA/Articles/abstract14471.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14470.html AngioDynamics, Inc. is voluntarily recalling all hospital inventory of Centros, a catheter used in dialysis. The Queensbury, N.Y.-based medical device manufacturer said it became aware that the catheter cuff, a component intended to anchor the catheter in the tissue just below the skin, was inadequately attached to the catheter in a few instances. AngioDynamics (Nasdaq: ANGO) has identified the cause of the cuff problem and believes it is related to an outside manufacturer's production process. Pending a review by the U.S. Food and Drug Administration, shipments of Centros are expected to resume during the company's fiscal third quarter, which begins Dec. 1. http://www.compliancehome.com/resources/FDA/Articles/abstract14470.html Mon, 14 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14469.html An FDA advisory panel has recommended against putting http://www.compliancehome.com/resources/FDA/Articles/abstract14469.html Fri, 11 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14455.html Heightened Food and Drug Administration surveillance for problems with products already on the market could pressure medical-device makers by boosting research-and-development costs and the risk of negative news, according to Moody's Investors Service. Manufacturers of high-tech devices such as drug-coated stents - which are made by Boston Scientific Corp. (BSX), Johnson & Johnson (JNJ), Medtronic Inc. (MDT) and Abbott Laboratories (ABT) - appear to be most vulnerable to the increased scrutiny, Moody's said in a report issued Thursday. The credit ratings firm examined the impact of an FDA plan announced in May, called http://www.compliancehome.com/resources/FDA/Articles/abstract14455.html Fri, 11 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14454.html Drug giant Pfizer Inc. (PFE) on Thursday defended its epilepsy drugs, telling federal regulators and medical experts the drugs minimally increase the risk of suicide and don't deserve additional labeling. The U.S. Food and Drug Administration has said it wants to add its toughest warning, known as a black-box warning, to more than 10 epilepsy drugs because of data showing they increase the risk of suicidal behavior and suicidal thinking. Adding such warnings could harm the $8 billion epilepsy market. Epilepsy is a common chronic neurological disorder that is characterized by recurrent unprovoked seizures. More than 10 million Americans took FDA-approved epilepsy drugs in 2007. http://www.compliancehome.com/resources/FDA/Articles/abstract14454.html Fri, 11 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14453.html This mornings news includes word the FDA is considering a new warning on epilepsy drugs, stating they can lead to suicide. (To the right, the fine print on such a warning.) Such warnings have become a popular replacement for regulation in recent years. A link between antidepressent use and suicide resulted in a warning. There is a new warning on antibiotics. Weve seen warnings placed on packages of diabetes drugs and drugs taken by kids for ADHD. Yet at the same time the agency is piling on uncertainty for drug consumers, it is also trying to remove their right to sue under the theory of preemption, the idea that its rules make moot lawsuits in state and federal court. http://www.compliancehome.com/resources/FDA/Articles/abstract14453.html Thu, 10 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14449.html Dr. Drus Chiropractic, Dru Aguilar, 438 Montford Ave., announces the Food and Drug Administrations (FDA) approval of the Erchonia3LT laser to use for pain relief in patients suffering from chronic and acute pain. The laser, created by Dallas-based Erchonia, has been proven through extensive testing to significantly reduce the level of pain symptomatic with a number of ailments. The Erchonia3LT is the first and only low-level laser approved for use in reducing pain. By contrast to the high-power, high-heat lasers that are used in various surgical procedures, Erchonia lasers produce a low-level, or cold, output that has no thermal effect on the bodys tissue. Instead, the laser serves to stimulate biological function positively. Low-level laser therapy is commonly used to treat conditions such as acute and chronic pain in a number of medical areas without negative side effects. http://www.compliancehome.com/resources/FDA/Articles/abstract14449.html Thu, 10 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14448.html When a drugmaker looking to market a new medicine announces it has received an http://www.compliancehome.com/resources/FDA/Articles/abstract14448.html Thu, 10 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14447.html Intel Corp. said it passed its first review by the Food and Drug Administration, a step in delivering a new system for aiding the home care of patients with chronic conditions. The chip maker said it received FDA clearance for Intel Health Guide, a set of technologies that includes a special-purpose touchscreen computer. The system is to be attached to medical devices, including blood-pressure monitors, glucose meters and weight scales, to gather data that is sent over the Internet to medical professionals. Louis Burns, an Intel vice president, acknowledged that others already offer devices for remote patient monitoring, but he said Intel's approach of closely involving patients in their own care is unusual. http://www.compliancehome.com/resources/FDA/Articles/abstract14447.html Wed, 09 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14440.html Nearly a thousand people have been sickened by salmonella linked to raw tomatoes. As that number increases the Food and Drug Administration is testing other types of produce commonly served with tomatoes.Tomatoes are still the leading suspect, but produce like jalapeno peppers, and cilantro are also getting attention.When the FDA issued warnings about certain raw tomatoes nearly a month ago the owners of El Gallo Mexican Supermarket took notice. http://www.compliancehome.com/resources/FDA/Articles/abstract14440.html Wed, 09 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14439.html U.S. Food and Drug Administration (FDA) Tuesday requested makers of certain antibiotics to add http://www.compliancehome.com/resources/FDA/Articles/abstract14439.html Wed, 09 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14438.html A Waltham pharmaceutical firm is among several antibiotic manufacturers being told by federal regulators to place a prominent black box warning on its drug. The Food and Drug Administration said yesterday that it has found evidence that fluoroquinolone drugs may lead to tendon ruptures, a serious injury that can leave patients incapacitated and needing extensive surgery. The FDA ruling applies to top sellers Cipro, made by Bayer, and Levaquin, which is made by Ortho-McNeil. It also applies to Factive, an antibiotic made by Walthams Oscient Pharmaceuticals Corp. http://www.compliancehome.com/resources/FDA/Articles/abstract14438.html Wed, 09 Jul 2008 00:00:00 CST http://www.compliancehome.com/resources/FDA/Articles/abstract14437.html It is highly likely that the source of the recent salmonella outbreak linked to raw tomatoes will not be traceable, claims the US Center for Food Safety and Applied Nutrition. Since April, 991 persons in 41 US states, the District of Columbia, and Canada have been infected with Salmonella Saintpaul linked to raw red plum, raw red Roma, or raw red round tomatoes and products containing these raw tomatoes, according to figures released yesterday by the Centers for Disease Control and Prevention (CDC). The FDA has so far been unable to trace back the source of the contamination. http://www.compliancehome.com/resources/FDA/Articles/abstract14437.html