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January 18, 2013News for the food and drug law community

  Drugs & Biologics 
  • Childhood vaccine schedule is safe, Institute of Medicine says
    A government-advisory body said there is no evidence that following the federally recommended childhood immunization schedule can lead to chronic diseases or developmental disorders. "The message is that the schedule is safe by all existing data," said Dr. Pauline Thomas, an Institute of Medicine adviser. CDC's guideline calls for 24 vaccinations by age 2 and allows children to get up to five vaccines in one office visit, but data indicate that up to 40% of parents follow alternative vaccine timetables for fear of adverse reactions. USA Today (1/16), The Wall Street Journal (1/16), Reuters (1/16) Email this Story
  • Europe issues draft guidance on cross-contamination thresholds
    Cross-contamination thresholds should be identified when more than one drug is made in the same production facility, the European Medicines Agency said in a draft guidance. Companies should know the threshold of toxicological concern or the permitted daily exposure by evaluating the available data from patient trials and laboratory tests. Treatments such as cytotoxic and highly active drugs, hormones, and antibiotics must be produced separately. (1/16) Email this Story
Get Creative: 10 Ways to Think Outside the Box
No matter your business, smart solutions come from out-of-the-box thinking. We all know creativity is king, but are you doing all you can to inspire and encourage creativity in your staff? Read the article and learn 10 ways to inspire creativity at your office.

  Global Focus 
  • EU regulators approve St. Jude's cardiac ablation device
    St. Jude Medical has earned CE mark approval to market its ViewFlex Xtra intracardiac echocardiography catheter in Europe. The device, which gained 510(k) clearance from the FDA last year, is used with the company's ViewMate Z Intracardiac Ultrasound Console to allow doctors to view a patient's cardiac anatomy in real time during heart ablation procedures. RTT News (1/17) Email this Story

Time and Attendance: The Core of Managing and Measuring Your Workforce
Based on data from Brandon Hall Group's 2014 Workforce Management Study, this paper explores the evolution of time and attendance, the impact of automation and integration, and the key role time and attendance solutions play in managing and measuring today's workforce. Read the Paper and Learn More

  Food & Dietary Supplements 
  • Lack of inspection causes Ill. firm to recall poultry products
    About 2,764 frozen poultry products are being recalled by Humphrey’s Market as these were distributed without inspection and could possibly include undeclared ingredients such as soy, milk and wheat. Affected products include packages of Lemon Pepper Chicken Breast and Bacon-wrapped Turkey Breast Fillet with five-ounce portions. (1/18) Email this Story
Combating Identity Theft in a Mobile, Social World
Mobile connectivity threats extend from consumers to the business environment. But who is really responsible for securing sensitive information? Smart business leaders are becoming proactive on the matter. Learn how to get protected in this white paper. Download the white paper now.

  Medical Devices 
Whitepaper: SDN: How do you get there from here?
Are the growing data needs of mobile, cloud, big data and social threatening today's enterprise networks? Scalable processes, a phased integration approach and the appetite to optimize over time are key components of a modern network. It's how agile organizations prepare for the data needs of tomorrow.
Explore the whitepaper to start down the path toward SDN.

  FDLI Items 
  • FDLI needs your opinion - Complete 30 Second Survey and be Entered to Win $100
    Technology is rapidly changing and FDLI wants to make sure we are leveraging technological advances and delivering our products and services in ways that meet your needs and preferences. We have developed a quick survey of five questions about your online educational preferences (online conferences and e-books). Please fully complete the survey by Jan. 25 to be entered to win one of two $100 American Express gift cards. Winners will be identified in a random drawing. Complete the 30-second survey online. (Hit refresh once if the survey doesn't automatically appear and you receive an error message in Internet Explorer.) Thank you in advance; your thoughts are very important to us as we consider new technology for serving the food and drug law community. Email this Story
  • Cosmetics Regulatory Process primer -- instant access, purchase and download now
    The Cosmetics Regulatory Process primer provides a baseline of key legal concepts and issues from experts in the field; describing, in detail, the basis of the underlying standards governing cosmetics and how cosmetic oversight differs from the regulation of food, drugs or medical devices. With this basic guide, readers will develop a firm grasp of the legal and regulatory concepts for cosmetics. Other available primers include:
    • The Medical Device Review Process: A Focus on Pre-Market Requirements
    • Controlled Substances: FDA and DEA Regulation of Pharmaceuticals
    Email this Story
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
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
Food and Drug AssociateHunton & Williams LLPWashington, DC
Regulatory ConsultantThe Weinberg GroupWashington, DC
Click here to view more job listings.

If you can't sleep, then get up and do something instead of lying there worrying. It's the worry that gets you, not the lack of sleep."
--Dale Carnegie,
American author and motivational speaker

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