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February 4, 2013News for the food and drug law community

  Drugs & Biologics 
  • Agency releases final Sunshine Act rule
    CMS on Friday released the final rule for the Physician Payments Sunshine Act, requiring drug and device companies to gather information on gifts, payments and other value transfers provided to doctors and teaching hospitals starting Aug. 1. The rule also requires manufacturers and group purchasing organizations to report ownership and investment interests by physicians. Modern Healthcare (subscription required) (2/1) Email this Story
  • House GOP sets deadline for FDA data on NECC-tied outbreak
    Republicans on the House Energy and Commerce Committee could issue a subpoena if the FDA fails to produce by Feb. 25 key internal memos regarding the meningitis outbreak tied to the New England Compounding Center. "FDA has produced no communications from staff and officials at FDA headquarters, who were actually making the decisions about how to address the situation," committee chairman Fred Upton, R-Mich., and four other Republicans wrote in a letter to the agency. FDA spokeswoman Erica Jefferson said the agency had provided more than 3,500 pages and is preparing on a response to the panel. USA Today/The Associated Press (2/1), Reuters (2/2) Email this Story
  • FDA warns against excessive use of acetaminophen
    People who take more than one over-the-counter drug containing acetaminophen and exceed the recommended daily dose are at risk of liver damage, and may develop flu- or cold-like symptoms, the FDA said. The agency also warned about the risk of combining alcohol and acetaminophen. HealthDay News (1/30) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • CMS issues plans to expand Medicare competitive bidding
    The CMS has issued plans for expanding competitive bidding for durable medical equipment, orthotics, prosthetics and supplies. The initiative's focus is "saving money for taxpayers and beneficiaries while preserving access to quality products from accredited suppliers," according to the CMS, but suppliers feel the program, along with a 2.3% tax, is squeezing the industry. New prices are set to take effect July 1. Clinica (subscription required) (2/1) Email this Story
  • Expanded Medicare bidding gets pushback from AdvaMed
    The Advanced Medical Technology Association has expressed concern over the CMS' decision to push ahead with pilot efforts to expand competitive bidding for durable medical devices. "The competitive bidding program is built in such a way that the lowest bid -- which may not be the right bid -- may compromise patient access to products best suited for their needs," AdvaMed President Stephen Ubl said. (Boston) (2/1) Email this Story
  • CryoLife gets warning letter over manufacturing concerns
    The FDA has issued a warning letter to CryoLife saying that the company failed to sufficiently fix earlier issues regarding manufacturing practices tied to some of its products. CryoLife will cooperate with the FDA in addressing the concerns raised in the letter, according to the company, which develops surgical devices and instruments. Reuters (2/1) Email this Story
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  FDLI Items 
  • Food Week 2013 starts tomorrow! -- Still time to register
    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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FDA/ORA/Asst Commissioner for Operations, Food and Drug Administration, Office of Regulatory AffairsFood and Drug AdministrationRockville, MD
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