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November 15, 2012News for the food and drug law community

  Drugs & Biologics 
  • Criticized at hearing, FDA calls for new authority
    The FDA needs new authority over drug compounders to prevent disasters such as the meningitis outbreak tied to tainted custom-made drugs from the New England Compounding Center, FDA Commissioner Dr. Margaret Hamburg told members of a House Energy and Commerce subcommittee. The present system "hampered our ability to act to protect patients and prevent, rather than just react to, safety concerns," Hamburg said. Several lawmakers sharply criticized the FDA, and committee Chairman Fred Upton, R-Mich., faulted the agency for not following up after finding problems years ago. The Hill/Healthwatch blog (11/14), The Washington Post (11/14) Email this Story
  • FDA proposes classifying compounding into 2 types
    Traditional and nontraditional compounding need different levels of oversight, according to the FDA. Traditional compounding of ingredients for specific patients on an as-needed basis needs less oversight than nontraditional compounding that is more akin to manufacturing, poses greater risks and needs more regulation, according to FDA Commissioner Dr. Margaret Hamburg's prepared remarks for her testimony Wednesday. Blog (11/14) Email this Story
  • MRSA treatment receives orphan drug status from FDA
    The FDA has given orphan drug status to Savara Pharmaceuticals' inhaled antibiotic AeroVanc, a treatment for pulmonary methicillin-resistant Staphylococcus aureus infection in people with cystic fibrosis. The drug is a dry, powdered formulation of vancomycin. "We hope to provide similar benefits to MRSA infected patients that tobramycin provides for the treatment of Pseudomonas aeruginosa infections," Savara CEO Robert Neville said. Pharmaceutical Business Review Online (11/14) Email this Story
  • FDA panel endorses Glaxo's avian flu vaccine
    The FDA's Vaccines and Related Biological Products Advisory Committee agreed unanimously to recommend approval of GlaxoSmithKline's Q-Pan H5N1 vaccine. Data from a Phase III trial revealed vaccine seroconversion rates exceeded the threshold for immunogenicity. (11/14) Email this Story
  • PhRMA: 221 new diabetes drugs are under development
    A total 221 new drugs for diabetes and related diseases are awaiting FDA approval or are in clinical studies, according to a report from PhRMA. The treatments in development include 130 for type 2 diabetes, 32 for type 1 diabetes, 14 for unspecified diabetes and 64 for diabetes-related conditions, with some medications in multiple categories. About 8% of Americans have diabetes PharmaTimes (U.K.) (11/14) Email this Story
  Global Focus 
  • EU approves first of a new class of diabetes drugs
    The European Commission approved Bristol-Myers Squibb and AstraZeneca's Forxiga, or dapagliflozin, to treat adults with type 2 diabetes. The decision makes Forxiga the first approved treatment from a new class of drugs called SGLT2 inhibitors. Forxiga, which works independently of insulin to regulate blood sugar, can be taken in combination with other type 2 diabetes drugs, or as a standalone therapy for patients who can't tolerate metformin. In January, the FDA did not approve the drug over concerns about liver and cancer risks. Reuters (11/14), The Miami Herald/The Associated Press (free registration) (11/14) Email this Story
  Food & Dietary Supplements 
  • FDA: Reports link 5-Hour Energy drink to 13 deaths
    The FDA received reports of 13 deaths in the past four years that cited the possible involvement of highly caffeinated drink 5-Hour Energy, which is distributed by Living Essentials. The reports' disclosure is the second in recent weeks that FDA filings citing deaths and energy drinks have emerged. The beverage was safe when used as directed, Living Essentials said in a statement. The New York Times (tiered subscription model) (11/14) Email this Story
  Medical Devices 
  • Venture capital group sees 2.3% device tax a top repeal priority
    The National Venture Capital Association has cited the 2.3% medical device tax set to begin next year as a top priority for repeal after the recent election. The group said the Democratic Senate might want to debate the levy "in the context of overall tax reform," a vision shared by AdvaMed, which in February issued a set of principles for amending the nation's tax system. (Boston) (11/14) Email this Story
  • Ikaria gets FDA OK for new software on infant drug delivery device
    The FDA has given Ikaria 510(k) clearance to update software on its Inomax DSIR device designed to deliver the firm's Inomax vasodilator agent, an FDA-approved treatment for infant hypoxic respiratory failure tied to pulmonary hypertension. The firm also gained FDA clearance for three devices used with the Inomax DSIR for noninvasive respiratory care. (Boston) (11/13) Email this Story
  FDLI Items 
  • Get first-hand knowledge from the first U.S.-based veterinary stem cell company
    Hear from Dr. Bob Harman, founder and CEO of Vet-Stem, the first U.S.-based commercial veterinary stem cell company, at FDLI's Regenerative Medicine: Key Developments in Regulation & Commercialization conference on Nov. 29 in Washington, D.C., and San Francisco. Dr. Harman is the CEO and principal clinical development director of the programs at Vet-Stem. Previously, he was the CEO of HTI-Bio-Services, a preclinical research company for veterinary and human pharmaceutical development. He has authored more than 500 contract study reports for animal health companies throughout the world and for submission to the FDA and USDA in support of the development of new animal and human health products. Don't miss the opportunity to hear Dr. Harman discuss the business of regenerative medicine. Email this Story

  • 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
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Nothing in life is to be feared. It is only to be understood."
--Marie Curie,
Polish-French physicist and chemist

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