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December 28, 2012News for the food and drug law community

  Drugs & Biologics 
  • Why Kalydeco is the FDA's biggest approval of 2012
    Of the 40 new drug approvals by the FDA this year, one stands out above the rest, Matthew Herper writes. The Cystic Fibrosis Foundation played a pivotal role in the development of Vertex's cystic fibrosis treatment Kalydeco, which directly acts on a gene that can cause cystic fibrosis, and groups such as the Michael J. Fox Foundation, the Multiple Myeloma Research Foundation and Myelin Repair are playing similar roles in drug development. Forbes (12/27) Email this Story
 
  • FDA warns 350 practices against unapproved versions of Botox
    The FDA warned more than 350 medical practices regarding unapproved versions of wrinkle fighter Botox as well as other drugs from Canada Drugs and its subsidiaries. The products could be unsafe, ineffective, counterfeit and contaminated, the FDA said. The FDA asked the practices to stop using the treatments in patients. Medical News Today (12/27) Email this Story
  • Judge rejects Mylan lawsuit against FDA over generic of Diovan
    U.S. District Court Judge John D. Bates dismissed Mylan's lawsuit against the FDA over the rejection of a generic form of Novartis AG's heart drug Diovan. Bates said the FDA didn't act in a capricious manner and "[g]iven Mylan's status as a leading generic manufacturer and its already-large market presence, the potential financial impact on Mylan's business is too small to support a finding of irreparable harm." Bloomberg (12/27) Email this Story
  • FDA has 2014 deadline for social media rules
    The FDA is directed to create social media rules by summer 2014 under a provision in a bill passed this summer, said Brian Reid, a director at communications firm WCG. The provision opens up several possibilities: the development of a comprehensive guidance document, congressional hearings if the FDA misses the deadline and small rule changes that integrate rather than separate social media guidance. Pharmalot.com/Pharma Blog (12/27) Email this Story
 
  • Alnylam CEO predicts more NME approvals in 2013
    Drugmakers have improved at developing innovative medicines, and the FDA has struck a better balance in assessing risks and benefits, writes Alnylam Pharmaceuticals CEO John Maraganore. The result will be increasing approvals of new molecular entities, he predicts. Xconomy/Boston (12/26) Email this Story
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  Global Focus 
  Food & Dietary Supplements 
  Medical Devices 
  FDLI Items 
  • Food "Hot Topics" -- Feb. 5, During Food Week 2013 -- You can't afford to miss these discussions!
      
    What challenges are food companies, regulators, and attorneys facing as the political landscape shifts toward grassroots movements? How are social media platforms changing how the food industry markets products and monitors press coverage? Hear in-depth discussions of these topics, as well as generally-recognized as safe (GRAS) developments and food truck regulations, during the "Hot Topics" conference during Food Week 2013. Learn more about Food Week 2013. Email this Story

  • New Policy Forum: Pharmacists' Duty to Warn Patients
     
    Gone are the days when the sole duty of a pharmacist consisted of accurately dispensing prescription drugs, according to Roseann B. Termini in FDLI's Dec. 12 Policy Forum. Termini, an adjunct professor at Widener Law, provides an overview of how courts around the country now treat a pharmacist's duty to warn patients. Termini concludes that courts should adopt the Hooks rule: that pharmacists are obligated to provide unsolicited information to patients about drug interactions, including addiction. FDLI members: Download now. | Nonmembers: Purchase for $24.95. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

 
Position TitleCompany NameLocation
Associate Director Regulatory Affairs - Advertising, Promotion & LabelingShireLexington, MA
Senior Counsel – Medical Device/Combination ProductAmgenThousand Oaks, CA
Counsel, Advertising and PromotionsMylan Pharmaceuticals Inc.Basking Ridge, NJ
Sr. Manager, Regulatory Affairs-Promotional ReviewNovo NordiskPrinceton, NJ
Assistant Commissioner for Compliance PolicyFood and Drug AdministrationSilver Spring, MD
Associate Commissioner for Regulatory AffairsFood and Drug AdministrationSilver Spring, MD
Assistant Commissioner for Compliance PolicyFood and Drug AdminstrationSilver Spring, MD
Click here to view more job listings.

  Editor's Note 
  • Correction
    A headline in a news item on Thursday incorrectly stated the number of nations that signed a statement of cooperation to develop the Medical Device Single Audit Program. Regulators for the U.S. and three other nations signed the statement. SmartBrief regrets the error. Email this Story
  SmartQuote 
No one has the right to be sorry for himself for a misfortune that strikes everyone."
--Marcus Tullius Cicero,
Roman philosopher and statesman


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