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January 17, 2013News for the food and drug law community

  Drugs & Biologics 
  • FDA outlines user fees for generic drug companies
    The FDA announced Wednesday that it has released user fee rates for generic-drug-makers that produce finished dosage forms and active pharmaceutical ingredients. Factories outside the U.S. will pay higher fees than domestic factories, in accordance with amendments to the Prescription Drug User Fee Act, the agency said. Drug Store News (1/16) Email this Story
  • FDA approves Protein Sciences' flu vaccine Flublok
    Protein Sciences received FDA approval for its new flu vaccine, Flublok, for patients aged 18 to 49. The vaccine "offers the potential for faster startup of the vaccine manufacturing process in the event of a pandemic, because it is not dependent on an egg supply or on availability of the influenza virus," an agency official said. The production method uses recombinant DNA and insect virus expression technology, which have been used in other vaccines. HealthDay News (1/17) Email this Story
  • Biogen, Elan seek expanded approval for MS drug Tysabri
    Biogen Idec and Elan have applied to the FDA and the European Medicines Agency for approval to market Tysabri as a first-line therapy for patients with relapsing forms of multiple sclerosis who were negative for antibodies to the JC virus. "A first-line approval would allow people with MS access to a highly efficacious treatment earlier in the course of the disease, potentially leading to better outcomes," Biogen Chief Medical office Alfred Sandrock said. The agencies' decisions are expected to come in 2013. Reuters (1/16) Email this Story
  • Tenn. eyes tighter regulation of sterile compounding
    The Tennessee Board of Pharmacy is considering additional regulation of the sterile compounding industry that officials say could lead to better oversight. A task force developed after an outbreak of fungal meningitis tied to a compounding pharmacy in Massachusetts has found that at least 352 pharmacies in the state practice compounding. A task force official said the state may adopt model regulations from U.S. Pharmacopeia and stressed the need for communication between state boards and the FDA. The Tennessean (Nashville) (tiered subscription model) (1/16) Email this Story
  • Advocacy groups press release of final rule on Sunshine Act
    Nineteen advocacy groups asked the Office of Management and Budget to release the final rule on the Physician Payments Sunshine Act, which mandates that medical device, biologic and drug companies report payments made to doctors. Delaying the law's implementation has "a significant consequence for [health care] system costs," the groups wrote. The Hill/Healthwatch blog (1/15) Email this Story
Why You Should Avoid Toxic Coworkers
A "spillover effect" from work neighbors can boost our productivity—or jeopardize our employment. Learn more through research from Kellogg School of Management Professor Dylan Minor.
  Food & Dietary Supplements 
  • Mo. cheese maker pulls product made from raw milk
    A voluntary recall of Flory's Favorite cheese was announced by Homestead Creamery due to possible E. coli contamination. Affected products, which have "Packed On 210" on their packaging, were sold at Homestead's facility in Jamesport, Mo., and possibly at several stores in Iowa and Missouri. (1/15) 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.
  Medical Devices 
  FDLI Items 
  • Attend first major conference on potential impact of food safety rules
    Do you know what's in those 1200+ pages of proposed regulations just issued by FDA under the Food Safety Modernization Act? You can find out directly from top FDA officials at the Food Safety Conference Feb. 7 -- part of FDLI's Food Week. The regulations -- Preventative Controls for Human Food and Produce Safety -- affect all food law, regulation and policy stakeholders, requiring food companies and processors to implement better controls to prevent outbreaks and deadly illnesses and requiring domestic and international farms to follow standards that would prevent contamination of fruits and vegetables. Take an interactive role in the first major conference to discuss the potential impact of these groundbreaking rules. Learn more about Food Week 2013. Email this Story

  • Food Advertising, Labeling and Nutrition: What to Expect in 2013 -- Feb. 6
    Mandatory and voluntary labeling options continue to proliferate. At FDLI's Food Week 2013 program on Food Advertising, Labeling and Nutrition (Feb. 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
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
Food and Drug AssociateHunton & Williams LLPWashington, DC
Senior Counsel – Medical Device/Combination ProductAmgenThousand Oaks, CA
Counsel, Advertising and PromotionsMylan Pharmaceuticals Inc.Basking Ridge, NJ
Compliance Counsel - PrivacyOtsukaPrinceton, NJ
Corporate AttorneyOtsukaRockville, MD
Corporate AttorneyOtsukaPrinceton, NJ
Regulatory ConsultantThe Weinberg GroupWashington, DC
Click here to view more job listings.

Passion, though a bad regulator, is a powerful spring."
--Ralph Waldo Emerson,
American writer

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