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January 8, 2013News for the food and drug law community

  Drugs & Biologics 
 
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  Global Focus 
  • Pharma acquisitions slow amid regulatory hurdles in India
    Compulsory license issues and foreign direct investment regulations have dampened the demand for domestic drugmakers in India. "Multibillion-dollar inbound deals have been slow to come, given the high valuation expectations of promoters, coupled with regulatory challenges," Avendus Capital's Deepak Gaurav said. However, "mid-market inbound pharma deals will continue to happen, given the attractive growth profile of the Indian market vis-a-vis other pharma markets globally." Business Standard (India) (1/7) Email this Story
Is Pricing Low Your Strategy to Success? Think again.
Pricing is the heart of a business. It affects everything you do and is affected by everything you do. Economists talk of supply and demand as key factors behind pricing—successful entrepreneurs manipulate demand by making their products more desirable. These six steps will help you determine the right price for your product or service, read the article and learn how to get pricing right.

  Food & Dietary Supplements 
  • Sunland can resume some work at peanut plant, FDA says
    Sunland can restart certain operations at its peanut mill in Portales, N.M., after the FDA moved to reinstate its food facility registration. The company's registration was suspended after peanut butter distributed by Sunland was linked to an outbreak of Salmonella Bredeney in 20 states. Additional corrective actions are required before the firm can resume distribution of ready-to-eat food. FoodNavigator (1/7) Email this Story
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  Medical Devices 
  • Latest hemodynamic monitor from Tensys scores 510(k) clearance
    The FDA has cleared Tensys Medical to market the latest product under its T-line suite of noninvasive hemodynamic monitors used in various clinical settings. The tablet-based device, called the TL-300, monitors beat-to-beat arterial waveform and blood pressure continuously, and displays trend information for as long as 12 hours. MedGadget.com (1/4) Email this Story
  • Delphinus pursues FDA OK for breast cancer device
    Delphinus Medical Technologies has submitted an application with the FDA for its SoftVue system, a 3D imaging device that could provide doctors with a safer and more precise alternative to mammograms in diagnosing breast cancer. CEO William Greenway said he hopes the company will get an FDA OK to begin marketing the device during the first half of 2013. Detroit Free Press (1/6) Email this Story
  • FDA approves study of Thoratec's ventricular assist device
    The FDA has granted Thoratec investigational device exemption approval to conduct a clinical study of its HeartMate II system, a ventricular assist device, to treat patients with NYHA Class III heart failure. The trial, which will involve as many as 100 patients, will compare the use of the device with "optimal medical management." MassDevice.com (Boston) (1/7) Email this Story
  Tobacco 
  FDLI Items 
  • Attend 1st major conference to discuss potential impact of food safety rules: Food Week 2013, Feb. 7
      
    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. When finalized, the regulations will require food companies and processors to implement better controls to prevent future outbreaks and deadly illnesses. 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

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

 
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Compliance Counsel - PrivacyOtsukaPrinceton, NJ
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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
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  SmartQuote 
A blunder at the right moment is better than cleverness at the wrong time."
--Carolyn Wells,
American author and poet


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