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November 1, 2012News for the food and drug law community

  Drugs & Biologics 
  • Millennium-Seattle's lymphoma drug gets conditional EU approval
    Millennium: The Takeda Oncology Company and Seattle Genetics obtained conditional approval from the European Commission to market Adcetris, or brentuximab vedotin, for adults with relapsed or refractory systemic anaplastic large cell lymphoma, as well as relapsed or refractory CD30-positive Hodgkin lymphoma who have received autologous stem cell transplants or at least two therapies when transplant or chemotherapy aren't appropriate. Seattle will receive $25 million for each approval. Genetic Engineering & Biotechnology News (10/31) Email this Story
  • FDA re-examines extended-release generics
    The FDA is taking a closer look at the techniques used by the makers of generic drugs to produce extended-release treatments after Impax Laboratories and Teva Pharmaceuticals' generic bupropion didn't work as well as brand-name depression drug Wellbutrin XL. "This has actually prompted us to change our policy," said Dr. Gregory Geba, head of the FDA's generic drugs office. The New York Times (tiered subscription model) (10/31) Email this Story
  Global Focus 
  Food & Dietary Supplements 
  Medical Devices 
  • EU approves next-gen drug-eluting balloon from Blue Medical
    Blue Medical Devices has obtained approval in Europe for the Protégé NC system, a next-generation version of the company's Protégé drug-eluting balloon. The newly approved device, which combines non-compliant balloon technology with a drug-eluting balloon, is intended for use in stent post-dilation as well as in treating in-stent restenosis. (Boston) (10/31) Email this Story
  FDLI Items 
  • Food Advertising: Claims, Litigation and Strategies -- Nov. 15
    In recent years, there has been a flurry of significant cases and regulatory actions in food advertising and litigation, including Lanham Act competitor suits and self-regulatory challenges, consumer class actions, FTC enforcement actions, and FDA warning letters. These cases, many still ongoing, have had far-reaching implications for all food product advertisers. In addition to specifically discussing genetically modified food labeling and disclosure, recent inquiries into energy drink marketing by the New York Attorney General, and FTC's case against POM Wonderful, speakers at FDLI's Food Advertising: Claims, Litigation and Strategies conference will address:
    • Claims and substantiation for functional foods and health claims;
    • Key cases and settlements in 2012, and a look ahead to 2013;
    • Current FDA and FTC priorities; and
    • Strategies for dealing with, and avoiding, litigation issues.
    View the detailed agenda on our website, and make sure to register before November 8 to take advantage of early-bird promotional pricing -- Save $100! Email this Story
  • Medical Device Primer: The Medical Device Review Process: A Focus on Pre-Market Requirements
    Instant access, purchase and download immediately
    This Primer walks readers through the process of determining whether a product qualifies as a medical device, describes the various FDA pre-market requirements, and details the numerous pathways for bringing a medical device to market, including 510(k) applications, Pre-market Approval Applications (PMAs), Investigational Device Exemptions, Humanitarian Device Exemptions, and Custom Devices. Members: $95 | Nonmembers: $119 | Order online. Email this Story

Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
FDA Regulatory AssociateArnold & Porter LLPWashington, DC
Regulatory Counsel, GlobalConfidentialNorthern, NJ
Senior Counsel - Regulatory and Quality Assurance ComplianceThe Procter & Gamble CompanyCincinnati, OH
corporate counsel, GA & Regulatory – Seattle, WAStarbucks Coffee CompanySeattle, WA
Health & FDA Business AssociateGreenberg TraurigWashington, DC
Click here to view more job listings.

Without deviation from the norm, progress is not possible."
--Frank Zappa,
American singer-songwriter

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