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January 25, 2013News for the food and drug law community

  Drugs & Biologics 
  • First botanical drug gets FDA nod
    Napo Pharmaceuticals has received federal approval for crofelemer, an orally administered herbal botanical, to address diarrhea in HIV patients. Crofelemer is the first botanical drug to be approved by the FDA, according to this report. Natural News (1/21) Email this Story
  • FDA considers reclassification of hydrocodone-containing drugs
    An FDA panel was set to this week to consider reclassifying hydrocodone-containing products from Schedule III to Schedule II drugs. "Even if we change hydrocodone-containing products from Schedule III to Schedule II, it in no way jeopardizes access. What this means is that patients who might be able to go to their doctor every six months would now have to see their doctor every three months [to get a prescription]," said Dr. Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing. HealthDay News (1/24) Email this Story
  • Senator urges action on final Sunshine Act regulations
    Sen. Chuck Grassley, R-Iowa, has asked the Obama administration to issue the long-awaited final rules on the Sunshine Act, saying the delays "are disrupting the considerable efforts of the pharmaceutical and medical device manufacturers that are already investing in systems to comply with the law." The law requires device and drug firms to report financial ties with doctors. (Boston) (1/24) Email this Story
  • Canada updates labeling for statins to add diabetes risk
    Health Canada revised the labeling for cholesterol-lowering statins to warn consumers about potential risk of developing type 2 diabetes. The change came 11 months after the FDA made a similar move in the U.S. Health Canada's slow action was criticized by drug safety researcher Dr. David Juurlink, who said "Canadians have a right to wonder why the agency tasked with protecting their health should act so much more slowly than its U.S. counterpart." (Canada)/The Canadian Press (1/24) Email this Story
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
  Food & Dietary Supplements 
  Medical Devices 
  • FDA gives Varian Medical nod on 2 cancer therapy systems
    The FDA has given Varian Medical Systems 510(k) clearance for a new version of the company's Vitesse system, which allows doctors to plan high-dose-rate brachytherapy for prostate cancer patients in real time. The FDA also has cleared the company's Edge radiosurgery system, which comes with motion management and real-time tumor tracking tools. RTT News (1/24) Email this Story
  • Myoscience gets FDA OK for handheld pain therapy device
    The FDA has cleared a next-generation version of myoscience's Focused Cold Therapy system for use in treating pain. The patented device, which administers cold therapy to targeted nerves, can be used to treat pain with no addictive potential or systemic side effects. (1/24) Email this Story
  • Welch Allyn's iPhone-based eye testing tool gets FDA OK
    Welch Allyn has secured 510(k) clearance from the FDA to market a device that links an ophthalmoscope, which is used to spot glaucoma and other eye conditions, with an iPhone. The iExaminer Adapter comes with a companion iPhone application to enable the sharing and printing of images. (1/23) Email this Story
  • EU approves SPR's nerve stimulation device for chronic shoulder pain
    SPR Therapeutics has obtained CE mark approval to market its Smartpatch Peripheral Nerve Stimulation device in Europe. The technology, which can be used for a maximum of 30 days, uses peripheral nerve stimulation to treat chronic shoulder pain. The company also is pursuing FDA approval for use of the device in treating post-amputation and post-stroke pain. (1/24) Email this Story
  FDLI Items 
  • Medical Device Compliance, Regulation and Litigation Conference -- March 4 -- CDRH Confirmed
    At this conference, now in its second year, attendees will hear Carolyn "Cassie" Scherer, policy advisor, Office of the Center Director, CDRH, FDA, and Mary Weick-Brady, senior policy adviser, Office of the Center Director, CDRH, FDA, discuss in detail the most significant recent, and upcoming, medical device compliance, regulatory and enforcement actions. Additionally, legal experts will analyze the most important cases of 2012 and detail what to expect in 2013 in litigation and regulatory developments, including key products liability issues. Register now and save $100. Email this Story

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--George Eliot,
British writer

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