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November 5, 2009 News for the biotech, medical device, drug and food regulatory profession     Drugs & Biologics  FDA program to curb medication errors The FDA plans to better prevent errors in dosing and dispensing of pharmaceuticals through the Safe Use program. As part of the program, the agency released guidance on dosage for makers of over-the-counter drugs that come with droppers or other dosing devices. The Washington Post (11/4) , CNN (11/4) 3 restraining orders placed on ZymoGenetics regarding Recothrom A federal court in Tennessee granted three temporary restraining orders against ZymoGenetics, preventing it from marketing Recothrom, a drug used to control hemorrhage. The orders came after King Pharmaceuticals and three other firms filed a lawsuit accusing ZymoGenetics of unfair competition and false advertising, among other claims. In a regulatory filing, the biotech firm denied wrongdoing and said it plans to "vigorously defend" itself against the allegations. American City Business Journals/Seattle (11/4) FDA grants orphan-drug status to GenVec's TNFerade GenVec received orphan-drug designation from the FDA for pancreatic cancer drug TNFerade. "The designation will strengthen the TNFerade program at GenVec by offering potential clinical development and commercialization benefits," CEO Paul Fischer said. American City Business Journals/Washington, D.C. (11/4) FDA expedites review of Shire's Gaucher disease drug The FDA gave Shire's velaglucerase alfa priority-review status as a treatment for Gaucher disease and a potential alternative to Genzyme's Cerezyme, which is in limited supply. The agency is expected to hand down its approval decision by Feb 28. The Boston Globe/The Associated Press (11/4) , Boston Herald (11/4)   Health Care in Transition  CBO: GOP health plan not as beneficial as Democrats' plan The House Republicans' health care reform proposal would reduce the number of uninsured Americans by only 3 million and cover only 83% of the eligible population by 2019, the Congressional Budget Office said in a new analysis. The report also says the Republican measure would reduce future federal deficits by $68 billion over a decade, compared with $104 billion by the Democrats' bill. The New York Times/Prescriptions blog (11/4) , The Washington Post/The Associated Press (11/4) , Los Angeles Times (11/5) Health reform plans don't address price, performance of devices As Congress works on a health care overhaul, medical devices appear to be an option to regulate Medicare spending. However, current reform proposals may not help because they don't contain provisions that would require device firms to compete based on the performance and cost of their products, some experts say. The New York Times (11/4) Other News AARP to back House health reform bill, sources say Google/The Associated Press (11/4)   Biotechnology  Zebrafish may offer clues to organ regeneration U.S. scientists studying zebrafish have discovered a cellular mechanism that seems to activate genes critical to organ regeneration. They also identified a biological catalyst protein, an enzyme that appears to play a role in the regeneration process. Telegraph (London) (11/4)   Food & Dietary Ingredients  Kellogg takes immunity claims off certain boxes of cereal Kellogg is removing banners from boxes of Rice Krispies and Cocoa Krispies that say the products can boost immunity. The company said it added antioxidants starting last year, and, "while science shows that these antioxidants help support the immune system, given the public attention on H1N1, the company decided to make this change." Advertising Age (11/4) , Star Tribune (Minneapolis-St. Paul, Minn.)/The Associated Press (11/4)   Featured Content    The Benefits of Outsourcing Your Billing Michelle V. Rafter Network-Attached Storage Is the New "Multifunction Printer" for SMBs Jon Stokes from Ars Technica Proper Credit Policies & Procedures Can Help Minimize Your Cash Flow Denise O'Berry 6 Desktop Apps for Better Organization & Focus Behance Team Five Keys to Sales When You Hate to Sell? Susan L. Reid   Medical Devices  Synthes issues recall over spinal implants Synthes voluntarily recalled Synex II Central Body components after it received six reports of adverse events, a move classified by the FDA as a Class I recall. The company has told surgeons and hospitals to stop using the spinal implants immediately. Reuters (11/4) , The Philadelphia Inquirer (11/4) Zimmer fails to get FDA panel's support for Dynesys implant An FDA panel voted against recommending Zimmer Holdings' Dynesys implant because studies failed to clearly demonstrate the safety and efficacy of the device in treating a spinal problem. A company official said Zimmer's data "demonstrated a reasonable assurance of safety and effectiveness" of the titanium implant. The Times-Picayune (New Orleans)/The Associated Press (11/4) FDA clears devices from Optima, Quick-Med The FDA has granted clearance to Optima Neuroscience for its IdentEvent device used for detecting seizures. The agency also cleared Quick-Med Technologies' Nimbus barrier gauze wound dressing for classification as a Class II medical device. The Gainesville Sun (Fla.) (11/4) See how Pilgrim Software used an unconventional marketing strategy to build market share in the life science and biotechnology industry and achieve Fortune 500 results at a fraction of the cost. Download this Life Science case study (free for SmartBrief subscribers).   FDLI Items  Monograph Series FDLI's Monograph Series is a groundbreaking set of six special reports specifically designed for attorneys, regulatory affairs and compliance specialists, manufacturers and consultants in the ever-changing food and drug field. The monographs are designed to provide you with inside information and proprietary analysis to enable you to advise your clients or help your company comply with vexing issues, regulations or guidance. View the titles. Purchase the series. Mark your 2010 calendar with FDLI program dates! 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