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February 19, 2013News for the food and drug law community

  Drugs & Biologics 
  • 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) Email this Story
  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) Email this Story
  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) Email this Story
  Medical Devices 
  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. Email this Story

  • 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. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
Position TitleCompany NameLocation
Advertising and Promotions CounselPrinceton Legal Search Group, LLCWashington, D.C., DC
Counsel II, Legal (Anti-corruption)Gilead SciencesFoster City, CA
FDA AssociateK&L GatesMultiple Locations, United States
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  SmartQuote 
The right to be let alone is indeed the beginning of all freedoms."
--William O. Douglas,
U.S. Supreme Court justice


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