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February 19, 2013 News for the food and drug law community   Drugs & Biologics    Gilead pulls lot of eye drug for AIDS patients due to particulate Gilead Sciences voluntarily recalled one batch of Vistide, or cidofovir for IV infusion, because some vials contain particulate matter. The treatment is for AIDS patients with cytomegalovirus retinitis. MedPage Today (free registration) (2/18) Drugmakers join effort to curb Rx abuse by athletes More drugmakers are helping the World Anti-Doping Agency in creating tests that can help detect the abuse of treatments to improve performance in sports. Two major companies and several smaller firms will share information about their drugs to WADA. Drugmakers have a key part to play in stopping the abuse of new prescription treatments, WADA officials said. The New York Times (tiered subscription model) (2/18) Sanofi submits candidate diabetes drug lixisenatide for FDA OK The FDA received Sanofi's application for lixisenatide, or Lyxumia in Europe, to treat diabetes. The drug's European launch is scheduled for this quarter. Reuters (2/19) Task force examines open-angle glaucoma treatments Medical and surgical treatments help reduce intraocular pressure and optic nerve damage in patients with open-angle glaucoma, according to a U.S. Preventive Services Task Force analysis. However, it is still unclear which of the available therapies works best, researchers wrote in Annals of Internal Medicine. Comments on the agency's draft Recommendation Statement for OAG will be accepted through March 18. PhysiciansBriefing.com/HealthDay News (2/18) Clinical Management Toolkit from MasterControl Effective management of a clinical study must incorporate not only all the activities and records that comprise a study, but the capacity to efficiently and rapidly assess status and development shifts at any given time. Download the toolkit. ADVERTISEMENT   Global Focus  EU approves MRI-safe defibrillators from Biotronik Biotronik has obtained CE mark approval to market its Ilesto 7 implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators in Europe. The devices, equipped with ProMRI technology, have a long battery life and are designed to be used safely with MRI scanners. MedGadget.com (2/15)   Food & Dietary Supplements  AquaBounty confident that biotech salmon will win FDA approval AquaBounty Technologies was disappointed by the FDA's decision to extend the public comment period for its biotech salmon, but it believes the delay won't affect its chances for approval. In 2010, an FDA advisory panel found the salmon posed no risk to safety or the environment. "There has been neither new information nor a clear legal or regulatory issue raised by the FDA since that time," AquaBounty CEO Ronald Stotish said. FoodNavigator (2/18)   Medical Devices  More than 9,000 medtech employees sign petition for device tax repeal More than 9,000 employees from the medtech sector have signed an online petition pressing for the repeal of the 2.3% medical device tax, which took effect last month. More than 200 congressional lawmakers also back the push to strike down the tax, according to no2point3.com, which published the petition. DOTMed.com (2/19) Oxford wins FDA nod for patient-specific cranial system The FDA has given Oxford Performance Materials 510(k) clearance to market its OsteoFab system. The implantable device, which is tailored to each patient, is designed to help replace skull voids caused by disease or trauma. BeckersASC.com (2/18) FDA sets review date for Abbott's aortic valve repair system A panel of FDA advisers will convene on March 20 to evaluate Abbott's MitraClip system for aortic valve repair. The company seeks to have the device approved for use in minimizing symptomatic mitral valve regurgitation in patients who are too weak to receive open-heart procedures. MassDevice.com (Boston) (2/15) Exact advances PMA application for colorectal cancer test Exact Sciences has submitted to the FDA the second module of its premarket approval application for Cologuard, a DNA test that uses stool samples to screen for colorectal cancer. The Madison, Wis.-based company plans to submit a third and final module using results from its DeeP-C pivotal clinical trial, which it said earlier are likely to be available by March. GenomeWeb Daily News (free registration) (2/18)   FDLI Items  Medical Device Compliance, Regulation and Litigation Conference -- March 4 This annual event for the medical device community brings together top experts at FDA to discuss the most significant recent and upcoming medical device compliance, regulatory, and enforcement actions. This year will also feature the implementation of FDASIA, products liability strategies, the pitfalls of clinical trials, and changes to the 510(k) clearance process. Register now. New Policy Forum: What Does the Second Circuit's Recent Decision in United States v. Caronia Not Say? This issue of FDLI's Policy Forum deconstructs the landmark decision in United States v. Caronia on when promotional activities by pharmaceutical manufacturers are protected as free speech and provides advice to the government for the prosecution of these cases in the future. Author Geoffrey R. Kaiser, former federal prosecutor of Caronia and current owner of Kaiser Law Firm, PLLC, asserts that Caronia has not appreciably changed the government's ability to prosecute misbranding offenses, but that the government may choose to not prosecute similar cases in the future. Kaiser recommends that courts allow the use of promotional speech as evidence that a drug or device has been marketed for an intended use inconsistent with its approved labeling. He also recommends that prosecutors ensure that their presentation of the evidence and their arguments to the jury are closely tied to the underlying behavior actually criminalized by the Food, Drug and Cosmetic Act. Learn more about FDLI -> About FDLI  |  Join FDLI  |  Conferences  |  Publications Position Title Company Name Location Advertising and Promotions Counsel Princeton Legal Search Group, LLC Washington, D.C., DC Counsel II, Legal (Anti-corruption) Gilead Sciences Foster City, CA FDA Associate K&L Gates Multiple Locations, United States Click here to view more job listings.   SmartQuote  The right to be let alone is indeed the beginning of all freedoms." --William O. Douglas, U.S. Supreme Court justice     Subscriber Tools       Print friendly format | Web version | Search past news | Archive | Privacy policy Advertise Account Director:  Meryl Harold (202) 407-7828 Download Media Kit Job Board:  Jackie Basso (202) 407-7871   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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