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February 20, 2013News for the food and drug law community

  Drugs & Biologics 
  • Teva, Gilead to settle dispute over HIV/hepatitis B drug Viread
    Gilead Sciences and Teva Pharmaceuticals agreed to settle a patent-infringement lawsuit tied to the former's chronic hepatitis B and HIV infection treatment Viread. "This settlement removes some uncertainty and minimizes further distraction and investment of human and financial resources associated with this litigation," Gilead President and COO John Milligan said. Reuters (2/19), Bloomberg (2/20) Email this Story
  • Okla. committee OKs bill on PBM oversight
    Oklahoma state Rep. David Derby, a Republican, persuaded the House Public Health Committee to support giving the Oklahoma State Board of Pharmacy the authority to regulate pharmacy benefit managers. The committee voted 7-3 in favor of Derby's proposed bill that would require PBMs to disclose more data to consumers and obtain a license from the pharmacy board. San Francisco Chronicle/The Associated Press (2/19) Email this Story
  • Other News
  Global Focus 
  Food & Dietary Supplements 
  • Colo.'s Polis to unveil GMO labeling bill
    U.S. Rep. Jared Polis, D-Colo., is sponsoring a bill to require the disclosure and labeling of food with genetically modified organisms. "It’s important to empower people with information they need to make their own healthy choices," Polis said. (2/20) Email this Story
  Medical Devices 
  • FDA issues draft guidance on third-party device review program
    The FDA has released draft guidance on changes to its program to accredit third-party entities to review certain medical device applications. The draft guidance, based on the International Medical Device Regulators Forum's proposal to create a unified program for medtech auditors, covers compliance with the FDA Safety and Innovation Act, including a provision regarding third-party firm accreditation. Firms must seek reaccreditation every three years. Clinica (subscription required) (2/19) Email this Story
  • Conn. panel to discuss ban on smoking in cars with children
    The Connecticut Transportation Committee today will discuss a bill that would prohibit smoking in vehicles with children in car seats, which are required in the state for all children under age 7 and under 60 pounds. "Until they're age 7, their immunity systems are not mature," said state Rep. Henry Genga of East Hartford, who has been pushing the bill. WTNH-TV (New Haven, Conn.) (2/18) Email this Story
  FDLI Items 
  • Commissioner Hamburg Confirmed! Don't Miss the 2013 FDLI Annual Conference
    FDLI's Annual Conference is the largest and longest-running legal conference for FDA-regulated industry and the entire food and drug law community. This advanced two-day program will cover legal, regulatory, policy and economic issues spanning the gamut of FDA's authority by bringing together experts from the Federal Government, industry, public sector, consulting organizations and academia. Register now and save $300. Email this Story

  • Instant access -- The Drug/Biologics Approval Process Primer
    This publication will explain, in practical terms, the approval processes for drugs and biologics. It will describe the various FDA premarket requirements and pathways for drug and biologics application reviews, including changes enacted under the Food and Drug Administration Safety and Innovation Act (FDASIA). Topics addressed will include the New Drug Application (NDA) process, non-NDA routes to market, generic drugs and the abbreviated new drug application process, as well as over-the-counter drugs and biologics. With this Primer, pharmaceutical stakeholders will feel confident that they have a helpful overview to support successfully navigating the FDA drug and biologics review processes. 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
Click here to view more job listings.

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