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January 7, 2013News for the food and drug law community

  Drugs & Biologics 
 
  • Ruling won't slow down off-label prosecutions of drugmakers
    The Justice Department's off-label investigations and pending settlements shouldn't be hampered by a recent U.S. Court of Appeals decision that some interpreted as protecting drugmakers from liability for off-label marketing of prescription drugs, lawyer Erika Kelton writes. The vocabulary used in describing violations will be different in future cases, putting emphasis on the terms "misbranding" and "intended use" more than "off-label" and "promotion." First Amendment rights aren't threatened by off-label cases that target misleading or false representations about the efficacy and safety of treatments, Kelton writes. Forbes (1/4) Email this Story
 
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  Global Focus 
  • Indian high court could decide drug patent case in early 2013
    India's Supreme Court is expected to rule early this year on whether domestic drugmakers can continue to offer generic versions of some treatments. Aid groups argue that the country plays an important role as pharmacy for the poor, while drugmakers argue the need for strong patents to make the development of drugs possible. "Across the world, there is a heavy dependence on India to supply affordable versions of expensive patented medicines," Doctors Without Borders' Leena Menghaney said. "This case is about safeguarding incentives for better medicines so that patients' needs will be met in the future," Novartis' Eric Althoff said. The Washington Times/The Associated Press (1/4) Email this Story
  • India plans tighter regulation of drug studies
    The Indian government plans to change laws governing drug trials to make violations by multinational corporations punishable and to improve compensation. Rules governing clinical studies under the Drugs and Cosmetics Act could be released this month. Trial investigators and sponsors would be required to address the medical management of subjects in cases of serious adverse events including death. The Economic Times (India)/Press Trust of India (1/4) Email this Story
  Food & Dietary Supplements 
  • FDA shifts focus to prevention in proposed food-safety rules
    The FDA proposed new food safety rules that would subject processors to stricter safety monitoring and require produce farmers to keep deadly bacteria off their fields. All aspects of growing and harvesting produce will be covered by the proposed safety standards. The proposal represents a shift from the current emphasis on reactions to disease outbreaks to disease prevention. The Wall Street Journal (1/4), FDALawBlog.net (1/6) Email this Story
  Medical Devices 
  • Minn. group aims to reverse changes to 510(k) process
    The Minnesota Medical Device Alliance has filed a petition asking the FDA to discontinue certain definitions and administrative measures that the group says unlawfully alter the 510(k) clearance process. The petition cites practices adopted by the FDA since 2009, including wrongly applying "assurance case" and risk mitigation principles to 510(k) criteria. MedCityNews.com (1/4) Email this Story
  • Soft Tissue's device to repair rotator cuff wins FDA nod
    Soft Tissue Regeneration has been cleared by the FDA to market a biodegradable scaffold for patients in need of rotator cuff repair and soft tissue augmentation. The STR Graft, set to be commercially available in 2014, is intended to reduce pain, minimize surgical failure and expedite patient recovery time. Healio (1/4) Email this Story
  • New medical device vigilance guidelines take effect in Egypt
    The Egyptian Drug Authority has finalized guidelines governing its medical device vigilance program, which details responsibilities for the agency's Medical Device Safety Department, device users and manufacturers. The guidance took effect on Jan. 1 and includes changes to a draft version released in 2011, including a new section on in vitro diagnostics. Clinica (subscription required) (1/4) Email this Story
  Hot Topics 

Top five news stories selected by FDLI SmartBrief readers in the past week.

  • Results based on number of times each story was clicked by readers.
  FDLI Items 
  • Don't Miss FDLI Food Week 2013: Feb. 5-8 in Washington, D.C.
      
    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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Position TitleCompany NameLocation
Compliance Counsel - PrivacyOtsukaPrinceton, NJ
Corporate AttorneyOtsukaRockville, MD
Corporate AttorneyOtsukaPrinceton, NJ
Regulatory ConsultantThe Weinberg GroupWashington, DC
Senior Counsel – Medical Device/Combination ProductAmgenThousand Oaks, CA
Counsel, Advertising and PromotionsMylan Pharmaceuticals Inc.Basking Ridge, 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
Sr. Manager, Regulatory Affairs-Promotional ReviewNovo NordiskPrinceton, NJ
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  SmartQuote 
Live as if you were to die tomorrow. Learn as if you were to live forever."
--Mahatma Gandhi,
Indian lawyer and activist


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