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January 30, 2013News for the food and drug law community

  Drugs & Biologics 
  • FDA panel endorses Boehringer's olodaterol for COPD
    An FDA panel voted 15-1 to endorse Boehringer Ingelheim's olodaterol as a treatment for chronic obstructive pulmonary disease. The panel believed that Boehringer provided substantial evidence of the safety and long-term efficacy of the drug, which would be sold as a soft mist inhaler under the name Striverdi Respimat. Bloomberg Businessweek (1/29) Email this Story
  • Reps call for FDA to reclassify hydrocodone drugs
    Reps. Vern Buchanan, R-Fla., and Edward Markey, D-Mass., have urged the FDA to reclassify painkillers containing hydrocodone from Schedule III to Schedule II. The move would limit the quantity of pills that could be dispensed at one time and would mandate a written prescription for the frequently abused drugs. The Hill/RegWatch blog (1/28) 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 
  • Indian drugmakers filed most DMFs in 2012
    Drugmakers from India submitted more drug master files with the FDA than companies from any other nation. The files are required for the third-party sale of drug ingredients in the U.S. Indian drugmakers filed 70 DMFs out of a total 143 in one quarter. Sun Pharmaceutical Industries, Lupin Pharmaceuticals and Dr. Reddy's Laboratories were among the top filers for the year. Business Standard (India) (1/30) Email this Story
  Food & Dietary Supplements 
  Medical Devices 
  • AdvaMed, others remobilize efforts to repeal 2.3% device tax
    The Advanced Medical Technology Association joined forces with two other industry groups to press Congress to repeal the 2.3% medical device tax as first payment due date arrives. "This tax is already resulting in layoffs, reduced investments in R&D and delays in significant capital improvements. We urge Congress to act swiftly and repeal this job-killing, innovation destroying, anti-competitive tax," AdvaMed President and CEO Stephen Ubl said. (Boston) (1/29) Email this Story
  • ReCor wins EU approval for 2nd-gen renal denervation device
    ReCor Medical has been cleared to market a new version of its ultrasound-based renal denervation device, which is used to control hypertension, in Europe. The PARADISE Gen 2 system improves on the original version with faster denervation and a 6 French over-the-wire device size. (1/29) Email this Story
  FDLI Items 
  • Food Week starts next week -- Food Safety and Global Developments
    The USDA released a notice on Friday outlining FSIS' recently modified three-part approach to verifying the equivalence of foreign food regulatory systems that export to the U.S. This new risk-based approach to food regulation is congruent with the FDA's own site-selection model for the frequency and scope of international inspections, and the self-reporting tool for exporters to complete in lieu of inspection will allow USDA to focus its resources on high-risk regions. To hear about how these changes will impact FSMA goals, register for Food Safety: Latest Regulatory Developments & Best Practices and Global Developments: What's Your GPS? conferences during FDLI's Food Week, Feb. 7 and 8. Email this Story

  • More about Food Week
    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
Learn more about FDLI ->About FDLI  |  Join FDLI  |  Conferences  |  Publications

Position TitleCompany NameLocation
FDA/ORA/Asst Commissioner for Operations, Food and Drug Administration, Office of Regulatory AffairsFood and Drug AdministrationRockville, MD
FDA/ORA/Regional Food and Drug DirectorFood and Drug Administration/Office of Regulatory AffairsMultiple Locations, United States
FDA AssociateK&L GatesMultiple Locations, United States
Sales Engineer 108473-02 UTC Climate, Controls & Security Carrier CorporationAustin, TX
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.

Good judgment comes from experience, and often experience comes from bad judgment."
--Rita Mae Brown,
American writer

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