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December 10, 2012News for the food and drug law community

  Drugs & Biologics 
  • Cubist's antibiotics wins fast-track designation from FDA
    The FDA granted qualified infectious disease products designation to CXA-201 and CB-315, two late-stage antibiotics from Cubist Pharmaceuticals. The designation qualifies both drugs for priority review and other considerations. CXA-201 is being developed as a first-line intravenous treatment for urinary tract infections and complicated intra-abdominal infections, while CB-315 is intended as an oral treatment for Clostridium difficile-associated diarrhea. Mass High Tech (Boston) (12/7) Email this Story
  • Data on compounding group's role sought by House panel
    The House Energy and Commerce Committee requested information from the International Academy of Compounding Pharmacists on its role in helping pharmacies interact with federal and state regulators. The move came as the committee continues to probe a meningitis outbreak tied to tainted compounded treatments. Ten lawmakers cited a media report that the group told pharmacists how to "sidestep" FDA requests for samples. Reuters (12/7) Email this Story
  • Prices of 652 common drugs to drop under India policy
    The prices of 652 drugs in India are likely to fall by 10% to 15% under the National Pharmaceutical Pricing Policy, according to this article. The policy, which will affect around 30% of the domestic drug market, covers diabetic treatments, gastrointestinal drugs, heart treatments and anti-infectives, among other drugs. Imported drugs will be included under the policy. Prices of original research products with patents in the country will be exempt from the policy for five years. The Economic Times (India) (12/9) Email this Story
  • Canada updates drug advertising standards
    The Canadian Pharmaceutical Advertising Advisory Board, which approves drug advertising, amended parts of the Code of Advertising Acceptance dealing with social media and the Internet. The new version, which will be enforced starting July 1, allows advertisers to include a URL or link to the terms of market authorization approved by Health Canada for the drug rather than attaching a copy. Financial Post (Canada) (12/7) Email this Story
  Food & Dietary Supplements 
  • FDA's approval sought to use genetically engineered mosquitoes
    Officials in Florida are asking for the FDA's OK to release biotech mosquitoes from the British company Oxitec to control a breed of mosquito that spreads dengue fever. Oxitec conducted a field test of mosquitoes designed to produce nonviable offspring in 2010 on Grand Cayman Island. No timetable is set for a decision, according to an FDA spokeswoman. ABC News/"World News" (12/8) Email this Story
  Medical Devices 
  • FDA panel sets review date for NeuroPace's epilepsy device
    An FDA panel will convene on Feb. 22 to evaluate NeuroPace's premarket approval application for the RNS System, an implantable device that uses neuromodulation to treat epilepsy patients. The meeting comes more than two years after the company submitted its PMA application for use of the device in minimizing seizures among patients who are at least 18 years old. (Boston) (12/7) Email this Story
  • N.C. senator seeks "fiscally responsible" way to repeal device tax
    Sen. Kay Hagan, D-N.C., is in talks with state business leaders to find viable ways to compensate for the estimated $30 billion in revenue from the impending 2.3% medical device tax, which she hopes to get repealed. "My number one priority is getting North Carolina back to work, and I believe that increasing the number of these good-paying jobs will be essential to our state's economic security," she said. (Boston) (12/7) Email this Story
  • FDA unveils new reporting tool for tobacco violations
    The FDA's Center for Tobacco Products introduced a new form for reports of possible tobacco product violations from the public and other stakeholders. The form will be easier to use, which will help the agency monitor compliance better, protect the country's youth and reduce the health burden of tobacco use on the public, the FDA said. Convenience Store News (12/7) Email this Story
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  FDLI Items 
  • FDCA Statutory Supplement, 2012 -- Order your copy of the new edition
    This new 2012 edition is fully updated to reflect the recent amendments to the Federal Food, Drug, and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Signed into law by President Obama in July 2012, FDASIA includes the Prescription Drug User Fee Act (PDUFA) V, the Medical Device User Fee Act (MDUFA) III, the Generic Drug User Fee Act (GDUFA) and the Biosimilars User Fee Act (BsUFA) as well as a number of other changes. These amendments are presented in track changes (additions are underlined; deletions are struck-through), making it easy to identify updates and changes to the law. Order now. Email this Story
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