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April 25, 2012News for the biotech, medical device, drug and food regulatory profession

  Drugs & Biologics 
  • Novartis takes legal action to protect Lucentis sales in U.K.
    Novartis sued units of the U.K. National Health Service to prevent doctors from prescribing Roche Holding's Avastin in place of Lucentis to patients with wet age-related macular degeneration. The NHS units said Avastin is more affordable for government coverage "in a time of substantial financial pressure." Novartis said patients' safety is compromised when "using an unlicensed medicine to treat wet AMD." The Wall Street Journal (4/24) Email this Story
  Global Focus 
  Food & Dietary Supplements 
  • USDA finds California dairy cow positive for BSE
    A dairy cow in central California that died last week had bovine spongiform encephalopathy, the state's first case since 2006, the USDA has confirmed. Meat from the cow has not entered the U.S. food supply, USDA Chief Veterinary Officer John Clifford said. State Food and Agriculture Secretary Karen Ross said "the detection of BSE shows that the surveillance program in place in California and around the country is working. Milk and beef remain safe to consume." USA TODAY (4/25), Reuters (4/24), MSNBC/The Associated Press (4/24) Email this Story
  Featured Content 

  Medical Devices 
  • AdvaMed expects timely approval of user fee reauthorization bill
    The U.S. House and Senate are scheduled this week to mark up a bill that would reauthorize the Medical Device User Fee & Modernization Act, earning applause from AdvaMed. "We are encouraged by the bipartisan support this legislation has received," said AdvaMed President and CEO Stephen Ubl, who expressed optimism that the bill will get timely approval. (Boston) (4/24) Email this Story
  • FDA OKs use of ActiViews' CT-Guide device in liver interventions
    ActiViews has obtained 510(k) clearance from the FDA for use of its CT-Guide needle guidance system in liver interventions. The device is intended to help doctors perform ablations, percutaneous biopsies, marker placements and other CT-guided interventional procedures in the liver and lungs less invasively. (4/24) Email this Story
  FDLI Items 
  • FDLI's Annual Conference is in full swing, follow us on Twitter
    Follow us on Twitter @foodanddruglaw and search #fdli to see what attendees are saying about keynote addresses and hot-topic breakout sessions on regulatory science; global developments and emerging markets; economic, legal and regulatory challenges of innovation; social media and mobile apps. Download presentations online and purchase audio from each session post-conference. Email this Story
  • theLINK: A Comprehensive FDA Directory -- special offer now Available
    Complimentary trial available through Thursday. theLINK's online edition features all of the content in the print edition as well as added Web features, and is updated to quickly reflect personnel changes. It also includes background information of many FDA staff, including education, former professional experience and speaking engagements. Save $250 on the online subscription, and $100 on the print subscription. Learn more. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
Junior to Mid-Level FDA & Healthcare AssociateMorgan LewisWashington, DC
AttorneyDept. of Health and Human Services, FDA, Office of the Chief CounselSilver Spring, MD
Senior and Principal P/T ConsultantsBecker & Associates ConsultingNationwide, United States
CounselVerto Solutions, LLCWashington DC, DC
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All things are difficult before they are easy."
--Thomas Fuller,
British churchman and historian

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