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December 26, 2012News for the food and drug law community

  Drugs & Biologics 
  • Nations act against threat of drug-resistant TB
    India, the U.S. and South Africa are taking steps to address the threat of drug-resistant tuberculosis. The FDA is set to rule this week on a new treatment for drug-resistant TB, while the CDC has a faster test to diagnose drug-resistant strains. The U.S. also is acting to alleviate shortages of TB treatments. The Wall Street Journal (12/25) 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 
  • India council to discuss drugmaker-doctor ties on Thursday
    The Indian National Development Council will meet Thursday to discuss the possibility of requiring that drugmakers disclose payments to doctors for lectures, consulting, research, entertainment and travel. "Mandated disclosure by pharmaceutical companies of the expenditure incurred on drug promotion, and penalty on the company and vetting of drug related material in continuing medical education would be considered," the NDC said. The Economic Times (India) (12/26) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  FDLI Items 
  • Food Advertising, Labeling and Nutrition: What to Expect in 2013 -- Feb. 6
    Mandatory and voluntary labeling options continue to proliferate, just as the bill introduced in the last Congress by Rep. Sue Myrick and Rep. Theodore Deutch, the "Carcinogen-Free Label Act of 2012" (H.R. 6601. At FDLI’s Food Week 2013 program on Food Advertising, Labeling and Nutrition (Feb. 6), attendees will hear first-hand from federal and state government officials, industry representatives and consumer protection advocates. Food stakeholders will also discuss the labeling of genetically modified foods and the effectiveness, as a policy matter, of food labeling. Learn more about Food Week 2013. Email this Story

  • Controlled Substances Primer -- purchase and download instantly
    This Primer takes a start-to-finish look at the regulatory system for controlled substances (pharmaceuticals with abuse potential), explaining the regulatory maze of the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act. This user-friendly guide provides what you need to know about federal regulation of controlled substances. Purchase and download instantly. Email this Story
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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 Counsel, Regulatory Attorney MERCK & COMPANY INC. North Wales, PA
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