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Building a National Framework for the Establishment of Regulatory Science for Drug Development Workshop Summary (2011) / Chapter Skim
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1 Introduction
Pages 1-4

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From page 1...
... today has a broad range of responsibilities, regulating fully 25 percent of the American economy, including 80 percent of the nation's food supply and all drugs, devices, dietary supplements, animal drugs, cosmetics, biologics, and tobacco products. These responsibilities go far beyond those mandated in the agency's originating legislation -- the 1906 Pure Food and Drugs Act2 and the 1938 Federal Food, Drug, and Cosmetics Act.3 The agency was initially established to prevent the entry of adulterated products into the public market; it was from its inception grounded in principles of scientific study in support of its core mission of regulating consumable goods.
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From page 2...
... To address these concerns, the IOM Drug Forum convened a public workshop on February 26, 2010, to examine the state of the science of drug regulation and consider approaches for enhancing the scientific basis of regulatory decision making. The workshop provided an opportunity to explore the concept of regulatory science, examine how it can be used to improve regulatory decision making, and consider alterna 4 The FDA Science Board is an advisory committee with the following mission: "The Board shall provide advice primarily to the Commissioner and other appropriate officials on specific complex and technical issues as well as, emerging issues within the scientific com munity, in industry and academia.
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From page 3...
... A range of approaches and innovative mechanisms were considered, including fostering the scientific discipline of regulatory science, promoting closer collaboration between regulatory and academic research ers, and developing a solid infrastructure to support regulatory science. Among the specific models discussed were regulatory science centers of excellence, innovative federal grant-making mechanisms, and medical education and professional development programs.
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From page 4...
...  ESTABLISHMENT OF REGULATORY SCIENCE FOR DRUG DEVELOPMENT • hapter 7 elaborates on the desired outcomes of successful imple C mentation of regulatory science. • hapter 8 summarizes next steps for enhancing regulatory science C offered during the workshop.
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Key Terms

  • drug development
  • drug regulation
  • drug forum
  • regulatory decision
  • drug discovery

  • science base
  • provide advice
  • drug evaluation
  • support regulatory
  • iom drug

  • regulatory evaluation
  • enhancing regulatory
  • improve regulatory
  • fda science
  • lilly research

  • enhanced science
  • workshop purpose
  • consider approaches
  • emerging issues
  • negative consequences

  • including infrastructure
  • appropriate officials
  • medical education
  • professional development
  • iom forum

  • innovative mechanisms
  • eli lilly
  • solid infrastructure
  • extramural funding
  • critical review


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