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November 20, 2012News for the food and drug law community

  Drugs & Biologics 
  • FDA expands approval of GSK-Ligand's platelet drug Promacta
    The FDA approved GlaxoSmithKline and Ligand Pharmaceuticals' Promacta, or eltrombopag, to treat low platelet count in people with hepatitis C, so they can receive standard treatment. The approval is the first for supportive care to help patients unsuited for interferon-based therapy because of low platelet counts. Reuters (11/19) Email this Story
  • Report: Advair sales rose despite health risks
    Sales of GlaxoSmithKline's asthma drug Advair increased following asthma treatment recommendations from doctors who received money from GSK and other drugmakers, according to an investigation by MedPage Today and the Journal Sentinel. Advair can be dangerous and has been overused, according to this article. The treatment may be making users more susceptible to severe asthma attacks while easing symptoms, Dr. Shelley Salpeter said. Milwaukee Journal Sentinel/MedPage Today (tiered subscription model) (11/17) Email this Story
  • Examine Medicare's effect on compounding, group urges
    The advocacy group Public Citizen asked HHS Secretary Kathleen Sebelius to look into Medicare's reimbursement structure in the wake of the meningitis outbreak tied to the New England Compounding Center. Public Citizen said Medicare policy may have contributed to the emergence of large-scale drug compounding and was "ambiguous and conflicting" about the use of compounded treatments. The Hill/Healthwatch blog (11/19) Email this Story
  • Hearings find FDA, state regulators could have stopped outbreak
    Congressional hearings and the papers they generated about meningitis deaths tied to the New England Compounding Center indicate that the FDA and state regulators had chances to prevent the outbreak. The records compiled by congressional committees reflect the need for a central data bank on licensed pharmacies, according to this article. The Tennessean (Nashville) (tiered subscription model) (11/18) Email this Story
  • FDA is given until end of month to hand over NECC records
    House Energy and Commerce Committee Chairman Fred Upton, R-Mich., and other Republican members told the FDA in a letter Monday that the agency has until Nov. 30 to submit documents connected to the New England Compounding Center and the meningitis outbreak linked to it. "We need these documents to identify any possible weaknesses in FDA's regulatory system that can be immediately corrected administratively or legislatively," according to the letter. The Hill/Healthwatch blog (11/19), Reuters (11/19) Email this Story
  • Democrats seek GAO investigation on role of GPOs in drug shortages
    Six Democratic members of Congress asked the Government Accountability Office to investigate whether group purchasing organizations for hospitals have had an effect on drug shortages and an increase in drug compounding. "Increased hospital reliance on compounded drugs should be a result of increased need not unfair pricing," Rep. Ed Markey, D-Mass., said. The letter suggests "anticompetitive, exclusionary contracts" between the organizations and makers of generic drugs should be examined. Blog (11/19) 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.
  Global Focus 
  Food & Dietary Supplements 
  Medical Devices 
  FDLI Items 
  • New primer: Medical Device Review Process: A Focus on Pre-Market Requirements
    This brand-new primer walks readers through the process of determining whether a product qualifies as a medical device, describes the various FDA premarket requirements and details the numerous pathways for bringing a medical device to market, including 510(k) applications, Premarket Approval Applications (PMAs), Investigational Device Exemptions, Humanitarian Device Exemptions and Custom Devices. Get instant access and download now. Email this Story

  • 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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French author, journalist and philosopher

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