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December 10, 2008 News for the biotech, medical device, drug and food regulatory profession   Drugs & Biologics  Drugmakers to limit ads, fine-tune strategy The industry is expected to unveil this week advertising restrictions amid financial concerns and criticism over the accuracy of information in ads. The Pharmaceutical Research and Manufacturers of America is also set to introduce guidelines that include setting a time period before companies can launch ads for newly approved treatments. The Wall Street Journal (tiered subscription model)/Dow Jones Newswires (12/9) FDA advisers endorse Genzyme's Synvisc-One A group of independent experts unanimously recommended approval for Synvisc-One, a single-dose formulation of Genzyme's injectable drug for osteoarthritis, an FDA spokeswoman said. Genzyme's application is supported by data from a trial showing significant pain relief after 26 weeks. Forbes/The Associated Press (12/9) NIH works on disclosure policies for federal grants Criticism from Congress prompted the NIH to work to improve policies that require researchers and universities to disclose federal grants to address conflicts of interest. The agency sought opinions from different sectors and may take six months to a year to formulate regulations, NIH acting Director Raynard Kington said. The Wall Street Journal (free content)/Health Blog (12/8) FDA orders additional study for Targanta antibiotic Targanta Therapeutics failed to secure FDA approval for oritavancin, an antibiotic for complex skin infections, and was asked to conduct another trial to determine efficacy and safety. Targanta said the agency expressed concern about two studies that reported deaths and adverse reactions among oritavancin users. Forbes/Reuters (12/9) Blah, Blah, ROI, blah, blah. Anyone can talk about results. SmartBrief delivers them. Target prospects by industry; capture a senior-level audience, gain actionable results and reporting. Learn why advertising in SmartBrief makes dollars and sense. Contact a SmartBrief ad expert today.   Biotechnology  Biotech sector seeks tax break from Congress The Biotechnology Industry Organization and other sector leaders are asking Congress to temporarily amend a tax law to provide cash-strapped life sciences firms with upfront rebates in exchange for forgoing tax deductions that they can get once they become profitable. Bloomberg (12/10), NYTimes.com (12/9)   Food & Dietary Ingredients  In reversal, FDA allows animal antibiotics The U.S. FDA will continue allowing cephalosporin antibiotics in food-producing animals, reversing its view after calling the practice a public health risk in July. Cephalosporins treat respiratory diseases in cattle and swine, but some public health officials argue that it can promote resistance and produce strains of bacteria that threaten human life. The Wall Street Journal (tiered subscription model) (12/9) U.S. beef on sale again in South Korea After months of anti-beef rallies and riots in downtown Seoul, three major retailers have starting selling U.S. beef again. Fears about mad cow disease were spurred by a false news program claiming Koreans carry a gene making them more susceptible to mad cow disease than Americans. The Washington Post (12/9) EU court fines France for refusing to enforce biotech crop rules The European Court of Justice has imposed a €10 million fine on France for its failure to implement a 2002 regulation that details how biotech crops could be cultivated in locations where regular crops are planted. The delay in applying the EU rules was prompted by opposition from environmentalists to bioengineered crops, the French government said. BBC (12/9) The Buzz(CORPORATE ANNOUNCEMENTS) Regulatory Affairs Consultancy - Speid & Associates, Inc. will work with you on international, US and European regulatory affairs. We are strategic, as well as tactical. We cover a wide arena of regulatory affairs from clin trial applications and INDs, to Common Technical Dossiers. Drug safety services offered. Click here. Contact Dr. Lorna Speid at 858-531-6640 or emailing lspeid@sndtm.com. Interested in learning more about advertising in FDLI SmartBrief? Contact Chris Pope at 202 737-5500 ext 295 or cpope@smartbrief.com.     Medical Devices  FDA approves transfusion system from Sunquest Information Systems The FDA has given marketing clearance to Sunquest Information Systems for its Transfusion Management application. The product can be incorporated into the company's blood-bank and laboratory data systems and can be accessed through portable computers. Health Data Management (12/9) PLC Medical Systems gets FDA clearance for device study PLC Medical Systems received FDA approval to begin a U.S. clinical trial aimed at testing the efficacy of its RenalGuard System in preventing contrast-induced nephropathy. The company also secured clearance to boost the number of subjects in the study from 246 to 406 patients. HealthImaging.com (12/9)   FDLI Items  Do you specialize in pharmaceutical product marketing, regulatory affairs, legal, medical affairs or late-stage R&D? Register today for the conference, Pharmaceutical Risk Management The enactment of REMS -- Risk Evaluation and Mitigation Strategy -- has changed the world of drug development and product marketing. Pharmaceutical and biotechnology companies who do not thoroughly understand the strategies and tactics of REMS do so at their own peril. At this conference, Jan. 13, 2009, experts in the field will provide theoretical and practical enlightenment while engaging the audience to become part of the discussion. Learn more and make your hotel sleeping room reservations. Register online. Register by fax. Come learn, get involved, make a difference! With more than 10,000 members and affiliates, with unrivaled expertise in our varied disciplines, FDLI is at the forefront of virtually every new initiative that makes our industries more compliant, more secure and careers more rewarding. So take a moment, and become an FDLI member today! If you join before Nov. 30, you will be invited as guest to FDLI's Holiday and Awards Reception on Dec. 4! Learn more about FDLI -> About FDLI  |  Join FDLI  |  Conferences  |  Publications Sr. Attorney - Clinical Research Wyeth Collegeville, PA Corporate Counsel Genentech South San Francisco Director, Compliance Salix Pharmaceuticals Raleigh, NC   SmartQuote  Too often travel, instead of broadening the mind, merely lengthens the conversation." --Elizabeth Drew, journalist and author     Subscriber Tools       Print friendly format | Web version | Search past news | Archive | Privacy policy Advertise Account Executive:  Meryl Harold (202) 407-7828 Download Media Kit Job Board:  Celia Rothschild (202) 470-1159   Read more at SmartBrief.com A powerful website for SmartBrief readers including: Industry Home Readers' Choice Search Archive Who's Hiring? 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