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February 21, 2013
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News on diagnostic and therapeutic innovations and regulatory science

  Top Story 
  • China issues new quality standards for drug distribution
    China's State Food and Drug Administration has issued new quality-control standards for drug distributors and retailers that cover record keeping, cold-chain management and transportation. The new regulations take effect in June but allow a three-year transition period for related drug enterprises. (China) (2/19) LinkedInFacebookTwitterEmail this Story
  • Spectroscopy method detects fake malaria-fighting tablets
    Researchers from the U.K. said a method related to NMR spectroscopy, known as nuclear quadrupole resonance spectroscopy, can be an effective way to detect fake drugs. Researchers used the technique to detect fake Metakelfin, an antimalarial drug, finding that the counterfeit tablets contained only 43% of the necessary amount of sulfalene. Researchers hope the method can be modified to identify other counterfeit drugs and harnessed for the development of a portable fake-drug detector. The findings were published in the journal Analytical Chemistry. Chemical & Engineering News (2/18) LinkedInFacebookTwitterEmail this Story
  Asia Pacific 
  • Australia reviews asthma treatment protocols for children
    Australia is examining the problem of treating asthmatic children with fixed dose combinations without first prescribing a single-ingredient product (inhaled corticosteroid), a practice that goes against the prevailing asthma management guidelines. The country's main pediatric advisory group considers extensive FDC use to be a serious issue of quality medical care. BioSpectrum Asia (2/20) LinkedInFacebookTwitterEmail this Story
  • Revenues for Australian medtech sector hit $12B in 2012
    The medtech industry in Australia reported $12 billion in revenues last year, a 4% increase over 2011 that marked solid growth for the sector. "This is comparable to 3% growth in employment, 5% growth in revenue and 4% growth in R&D, which is the best test of future growth of the industry," aid Anne Trimmer, CEO of the Medical Technology Association of Australia. Clinica (subscription required) (2/18) LinkedInFacebookTwitterEmail this Story
  North America 
  • FDA issues draft guidance on third-party device review program
    The FDA has released draft guidance on changes to its program to accredit third-party entities to review certain medical device applications. The draft guidance, based on the International Medical Device Regulators Forum's proposal to create a unified program for medtech auditors, covers compliance with the FDA Safety and Innovation Act, including a provision regarding third-party firm accreditation. Firms must seek reaccreditation every three years. Clinica (subscription required) (2/19) LinkedInFacebookTwitterEmail this Story
  • Firms ally to develop plant-based drugs
    Caliber Biotherapeutics and iBio agreed to jointly develop and produce recombinant plant-based biopharmaceuticals using Caliber's plant-based production expertise and the iBioLaunch platform. The partners will initially work on a monoclonal antibody for cancer. iBio will get license and milestone fees and sales royalties on products arising from the collaboration. Genetic Engineering & Biotechnology News (2/19) LinkedInFacebookTwitterEmail this Story
  • Study: One-third of cancer chemotherapies employ off-label drugs
    Approximately one-third of all cancer chemotherapies have not been approved by the FDA for that particular treatment, according to a new study. "The main criticism of off-label prescribing has been the concern that it jeopardizes patient safety because the full risk-benefit ratio is often not completely understood," wrote University of Toronto researcher Monika Krzyzanowska. The study did not examine the question of whether such off-label treatments are effective. Yahoo/Reuters (2/19) LinkedInFacebookTwitterEmail this Story
25th EuroMeeting Amsterdam 2013, 4-6 March, RAI, Amsterdam, The Netherlands
  Latin America 
  • Brazil's medtech, drug companies to comment on government regs
    Anvisa, Brazil's regulatory agency for health care products, is giving the industry an opportunity to comment on its review procedures and regulations for 2013-2014. The consultation process encompasses more than 200 of Brazil's health care groups, including associations for medical device importers, implant manufacturers and dealers, and diagnostic laboratories. Clinica (2/19) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • Meeting India's regulatory challenges
    The president of the Global Pharmaceuticals Business at Ranbaxy Laboratories, Rajiv Gulati, will speak on the theme "India, the Upcoming Economy: Encouraging Enforcement of Regulation" at the 6th Regulatory Conference in India. The event, to be held in Ahmedabad, Gujarat from April 5 to 6, will bring together the region’s best talent in the pharmaceutical world to discuss the current challenge of keeping the Indian pharmaceutical industry competitive in the world market despite ever-evolving regulation. Read more. LinkedInFacebookTwitterEmail this Story

  • Share knowledge worldwide
    The Professional Poster Program at the DIA 2013 49th Annual Meeting, to be held in Boston from June 23 to 27, gives professionals an opportunity to present research to a diverse group of scientific colleagues who are actively involved in the discovery, development and life cycle management of pharmaceuticals, biotechnology, medical devices and health care-related products. Submit your professional poster before Feb. 28. LinkedInFacebookTwitterEmail this Story
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We must travel in the direction of our fear."
--John Berryman,
American poet and scholar

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