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The New Profile of Drug-Resistant Tuberculosis in Russia A Global and Local Perspective: Summary of a Joint Workshop by the Institute of Medicine and the Russian Academy of Medical Science (2011) / Chapter Skim
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9 The Development of New TB Diagnostics and Drugs
Pages 95-100

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From page 95...
... • egulatory authorities need to work closely and continuously with R academia, industry, and government agencies to inform strate gies for data collection, identify emerging concerns, and promote research needed for regulatory decisions. 1 This chapter and the key messages summarized at the beginning of the chapter are based on the presentation of Margaret Hamburg, U.S.
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From page 96...
... Yet the same principles that guided the response in New York City apply globally. TB must be detected in all its forms as early as possible, which requires focused attention on at-risk populations and on a host of social, economic, and clinical variables.
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From page 97...
... Five such drugs have entered clinical trials, with others in preclinical development (Global Alliance for TB Drug Development, 2010)
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From page 98...
... Last year, for example, an FDA advisory committee recommended the accelerated approval of new drugs for MDR TB on the basis of sputum culture conversion, which could reduce by years the time required for the delivery of new, more effective treatments to patients. In addition, biomarkers have great potential value for TB vaccine research
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From page 99...
... Regulatory authorities also have a responsibility to monitor drugs and other medical products once they enter the marketplace to ensure safety and appropriate use throughout the products' life cycle. Hamburg expressed her desire to see the FDA play an active role throughout the development of safe and effective tools to combat TB for the benefit of the American people and the world.
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Key Terms

  • regulatory authorities
  • clinical trials
  • medical products
  • regulatory pathways
  • hamburg emphasized

  • emerging concerns
  • stem cells
  • cell therapy
  • hamburg observed
  • stem cell

  • entered clinical
  • essential role
  • clinical trial
  • drug development
  • hamburg expressed

  • identify emerging
  • sputum culture
  • major therapeutic
  • efficient dose
  • drug discovery

  • breakneck speed
  • monitor drugs
  • novel candidate
  • inform strategies
  • american people

  • accelerated approval
  • community currently
  • continual developments
  • product review
  • innovative approaches


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