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January 3, 2013News for the food and drug law community

  Drugs & Biologics 
  • FDA drug approvals hit 16-year high in 2012
    The FDA approved 39 new drugs in 2012, the most since 1996, suggesting growth prospects for branded drugmakers that have been losing business to patent expirations. The approvals included potential blockbuster drugs such as Pfizer and Bristol-Myers Squibb's blood thinner Eliquis, but many are intended for smaller markets, including Vertex Pharmaceuticals' Kalydeco, which treats a particular form of cystic fibrosis. The Prescription Drug User Fee Act "provided critical resources for improving the quality and timeliness of premarket review of drugs," FDA spokeswoman Sandy Walsh said. Reuters (12/31), Bloomberg (1/2) Email this Story
  • Indian pharma faces multiple regulatory questions in 2013
    Indian drugmakers are facing several regulatory challenges this year, including the proposed introduction of a bill to monitor the relationship between medical practitioners and drugmakers, the issue of foreign direct investment in brownfield pharma and the Supreme Court's final ruling on the National Pharmaceutical Pricing Policy. Drugmakers also may reconsider their product portfolios and business strategies in light of patent expiries in the U.S. and other developed markets as well as increasing generic penetration. Business Standard (India) (1/2) Email this Story
  Global Focus 
  Food & Dietary Supplements 
  • USDA confirms elimination of produce testing program
    An official from the USDA confirmed the elimination of the Microbiological Data Program that performed 80% of all produce testing for salmonella, listeria and other pathogens. The produce industry said the program did not boost public health since most of its recalls were declared after produce had been eaten or after its expiration date. (1/3) Email this Story
  Medical Devices 
  • "Fiscal cliff" bill hurts advanced imaging sector
    The House of Representatives on Tuesday approved the Senate's "fiscal cliff" bill, which postpones for a year a 27% Medicare reimbursement reduction under the sustainable growth rate formula. The legislation, however, also has $800 million in Medicare fee cuts involving advanced medical imaging services. The bill increases the technical component equipment utilization rate for advanced imaging tests from the current 75% to 90% starting in January 2014. (free registration) (1/2), (1/2) Email this Story
  • Effort to repeal 2.3% device tax will continue, AdvaMed says
    The 2.3% medical device tax has taken effect after Congress reached a deal to prevent the "fiscal cliff" on Tuesday. The industry, however, has vowed to continue the push to repeal the levy, which Advanced Medical Technology Association President and CEO Stephen Ubl said is "premised on the recognition that the tax is costing jobs and threatening patient care." (Boston) (1/2) Email this Story
  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 (February 6th), 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

  • Download now -- The Medical Device Review Process: A Focus on Pre-Market Requirements
    This Primer explains, in practical terms, the medical device review process. The publication 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, download now. Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
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
Click here to view more job listings.

Trust only movement. Life happens at the level of events, not of words."
--Alfred Adler,
Austrian medical doctor and psychotherapist

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