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December 4, 2008 News for the biotech, medical device, drug and food regulatory profession   Drugs & Biologics    FDA teams up with WebMD for consumer-health alerts The FDA and WebMD are collaborating to improve the agency's ability to deliver product-safety and other health information to the public. Under the agreement, WebMD will publish FDA updates on its Web site as well as in its bimonthly magazine. United Press International (12/3), Health Data Management (12/3) Final report: Artificial chemical contaminated Chinese heparin A synthetic chemical called oversulfated chondroitin was responsible for batches of tainted heparin that came from China, U.S. investigators said in their final report. Patients began experiencing adverse effects including nausea, shortness of breath and a plunge in blood pressure within 30 minutes after taking the contaminated blood thinner, according to the report. U.S. News & World Report/HealthDay News (12/3) FDA advisers recommend approval for Novartis' Coartem An FDA advisory committee concluded that Coartem, a malaria treatment from Novartis AG, is safe and works against infections caused by the parasite P. falciparum. The drug, which is administered twice a day for three days, would be the first artemisinin-based combination therapy for malaria in the U.S. should it win FDA approval. The Wall Street Journal (tiered subscription model) (12/3) KV Pharmaceutical faces lawsuit from shareholders A San Diego law firm filed a suit on behalf of shareholders who claim that KV Pharmaceutical concealed problems at its manufacturing plants, leading to a voluntary recall of five products sold by the company's generic-drug unit, Ethex. KV did not immediately respond to a request for comment. American City Business Journals/St. Louis (12/3) Advanced Life Sciences granted FDA review for antibiotic The FDA agreed to evaluate Advanced Life Sciences' cethromycin, a once-daily antibiotic that treats mild to moderate community-acquired pneumonia. The announcement comes after the company reported positive data from a late-stage trial that found cethromycin more effective than Abbott Laboratories' Biaxin. The agency plans to complete its review in 10 months. CNNMoney.com/The Associated Press (12/3) Managing the medical issues of your case Organize the medical issues of claims and litigation in record time. Industry leader Litigation Management, Inc. (LMI) provides a full range of record collection and medical analysis services, while SmartCase provides a robust web tool for those who prefer the "do-it-yourself" approach.   Biotechnology  Study warns of Web sites promoting stem cell therapies Patients should beware of Web sites marketing safe and effective stem cell therapies because such claims are not supported by adequate scientific proof, according to a study. Researchers studied 19 sites found via Google in 2007 that touted such treatments in countries including China and Mexico but not the U.S. The International Society for Stem Cell Research criticized the promotion of unproven regimens. Yahoo!/The Associated Press (12/3)   Food & Dietary Ingredients  EU bans Chinese soy imports Imports of Chinese soy-based food products intended for infants and young children have been banned by the European Commission, and all other soy products will be tested when imported. The decision was made after melamine was found in Chinese soybean meal. BBC (12/3)   Medical Devices  Consumer advocates object to Web ads of medical devices A nonprofit consumer group filed a petition with the FDA, asking the agency to order Medtronic and two other device makers to remove their online advertisements from YouTube. Prescription Project said the materials breach federal regulations because they highlight the benefits of the products but fail to detail the risks. The group also urged the FDA to update its rules to address Internet promotions. Medtronic has removed the online ad, which it says may have been uploaded by "third parties." Yahoo!/The Associated Press (12/3), The Wall Street Journal (tiered subscription model) (12/4) Edwards Lifesciences faces scrutiny over unapproved device Sen. Charles Grassley, R-Iowa, is looking into allegations that Edwards Lifesciences Corp.'s Myxo Ring, an annuloplasty product used in heart valve repair, is being used in patients at a Chicago hospital without FDA approval. The company said it has pulled the device from its Web site and halted its distribution. Reuters (12/3) Medtronic gets FDA approval for defibrillator lead The FDA has granted approval for Medtronic's Sprint Quattro Secure lead, which is designed to be used with the company's implantable defibrillators. The product could help surgeons treat people with unusual anatomies, Medtronic said. Google/The Associated Press (12/3)   FDLI Items  Preview now FDLI's "A Practical Guide to Food and Drug Law and Regulation, 3rd Edition" This significantly updated third edition, including incorporation of the Food and Drug Administration Amendments Act and other new laws passed since 2002, provides readers a practical explanation of food and drug law and regulations in simple, nontechnical terms. This FDLI best-seller includes three new chapters: Combination Products, Pharmacovigilance and Regulation of Medical Research. "A Practical Guide" remains the single best resource for anyone needing a basic, uncomplicated understanding of the myriad requirements enforced by FDA. Preview now! Purchase through FDLI's Web site. Purchase by using FDLI's fax order form. Know about omega-3 labeling, as featured in SmartBrief on Nov. 20? Learn about labeling, claims and food safety by attending Introduction to Food Law and Regulation, Jan. 27 and 28, 2009 During this interactive program, you will learn the essential elements of food law and regulation while acquiring an orientation to administrative agencies and furthering your understanding of how FDA, USDA and FTC promulgate and enforce regulations. This meeting will provide you with a context for keeping current with emerging issues of concern to food manufacturers, regulators and consumers, such as claims, safety, imports, allergens, advertising and bioterrorism measures. Pending state approval, Continuing Legal Education credits will be awarded. Read more. Register online. Register by fax. Read the SmartBrief article. 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