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February 1, 2013News for the food and drug law community

  Drugs & Biologics 
  • Glaxo refuses settlement in U.K. Avandia diabetes cases
    Despite settling U.S. lawsuits over claims that the diabetes drug Avandia causes heart attacks and strokes, GlaxoSmithKline has decided to fight similar claims in the U.K. It has become “increasingly difficult in the U.K. to challenge large corporations such as pharmaceutical companies," said Liz Thomas, policy manager at the patient-safety charity Action against Medical Accidents. blog (1/30) Email this Story
  • Makers of combo drugs petition FDA on exclusivity period
    Two drugmakers have petitioned the FDA to change how market exclusivity is granted for combination drugs. The agency grants five years' exclusivity only if all active compounds in a combination drug are new. The drugmakers are asking the FDA to consider that protection for combinations that include any previously unapproved active ingredients. Blog (1/31) Email this Story
  • Beanne warning letter could be sign of greater foreign focus by FDA
    The FDA issued a warning letter to Beanne Chemical for what the agency said were violations of current good manufacturing practices, including failure to correctly validate manufacturing procedures, maintain laboratory raw data and perform in-process testing. The second cGMP warning this year for a foreign manufacturer could be a sign of more to come from the FDA, according to this article. (1/30) Email this Story
  Global Focus 
  • Revised EU medtech vigilance policy includes ART, IVF systems
    The European Commission has issued revised guidance governing its medical device vigilance programs, which will go into effect in July. The revision is meant to provide explicit language on devices used in assisted reproduction technology and in vitro fertilization procedures as well as to clarify the monitoring of devices not intended to directly affect patients. Clinica (subscription required) (1/31) Email this Story
  Food & Dietary Supplements 
  • 20 years later: A look at new policies since Jack in the Box
    The 1993 outbreak of E. coli O157:H7 traced to undercooked meat at Jack in the Box put the bacteria on the nation's food-safety agenda. In response, new testing for E. Coli O157:H7 was required for ground beef. Since then, testing has expanded to other beef products, six additional strains have been added to the adulterant list and Hazard Analysis and Critical Control Points analyses are required. (2/1) Email this Story
  Medical Devices 
  • Companion diagnostics change cancer drug development
    Qiagen filed its application for FDA approval of a test for epidermal growth factor receptor in lung tumors simultaneously with Boehringer Ingelheim's request for approval of a drug that targets the gene mutation. Diagnostic tests help clinicians determine whether drugs that target specific gene mutations will work in individual patients, but insurers hesitate to reimburse diagnostics in the absence of proof that they improve drug efficacy. When tests are developed and approved in tandem with drugs, reimbursement is more likely, says Qiagen’s Stephen Little. Xconomy/Boston (1/31) Email this Story
  • FDA OKs broader use of ergo imaging system
    Digirad has received FDA clearance for expanded use of its ergo imaging system. The broader clearance covers lymphatic scintigraphy and parathyroid scintigraphy for evaluation of lesions in the breast and elsewhere in the body. The device was first cleared three years ago by the FDA. (1/31) Email this Story
  • Malaysia issues final regulations for medical devices
    The Malaysian government has published comprehensive regulations for medical devices, covering such areas as registration, licensing, export permits and procedures for appealing decisions. The effective date is July 1, with a two-year transition period for devices already on the market. Clinica (1/29) Email this Story
  FDLI Items 
  • Food Week 2013 starts Tuesday -- register today, don't miss out!
    FDLI's Food Week 2013 program is a unique opportunity for food law, regulation and policy stakeholders to hear first-hand from government officials and industry experts on the latest legal and regulatory developments. Food Week 2013 is a collection of four advanced one-day conferences, as well as FDLI's industry standard "Introduction to Food Law and Regulation" course. At this unique program, you set the menu -- attend one, two, three or all four conferences to make the most of your Food Week 2013 experience. Email this Story
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A man can fail many times, but he isn't a failure until he begins to blame somebody else."
--John Burroughs,
American naturalist and essayist

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