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Advancing the Discipline of Regulatory Science for Medical Product Development An Update on Progress and a Forward-Looking Agenda: Workshop Summary (2016) / Chapter Skim
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2 Characterizing the Regulatory Science Landscape
Pages 5-10

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From page 5...
... In considering ways to further advance the discipline of regulatory science, the workshop focused on ways in which information can be best generated, analyzed, integrated, and shared across regulatory science applications. In the opening session, workshop co-chair Alastair Wood, partner, Symphony Capital, and Professor of Medicine and Pharmacology, Weill Cornell School of Medicine, observed that there has been an explosion in the information available to the regulator that did not exist even 2 or 3 years ago.
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From page 6...
... , and workshop keynote speaker, noted that to accomplish these challenges, it would prove valuable for the greater scientific and clinical ecosystem to think broadly about the definition of the regulatory science endeavor, beyond FDA functions. INNOVATIVE SCIENCE AT FDA As the nation's principal consumer product protection agency and promoter of the nation's public health and health care systems, FDA serves as the linchpin of regulatory science.
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From page 7...
... The recommendations addressed opportunities for improvement in the following areas: • Medical product innovation • Food safety and applied nutrition • Product manufacturing and quality • Modernizing toxicology • Leadership and coordination Ostroff summarized the report's recommendations with the following perspective, "We [at FDA] need to study and support development of innovative ways to streamline, supplement, and speed medical product availability without having any negative impact on what we consider to be the FDA gold standard of being able to evaluate product efficacy and safety." Numerous workshop participants stressed that rigorous evaluation of the contemporary state of regulatory science will be instrumental in dynamically regulating the scientific and medical enterprises of the future.
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From page 8...
... Establishing standards for mobile health software quality control   7. Implementing validated electronic infrastructure for clinical trials and post marketing data collection   8.
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From page 9...
... Based on those proposals and additional conversations with European and U.S. regulatory agencies, the CERSI leadership identified 10 key examples of data science themes in regulatory science (see Box 2-1)
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Key Terms

  • fda science
  • data science
  • medical product
  • traditional scientific
  • ostroff noted

  • key examples
  • allows regulatory
  • evaluating regulatory
  • regulatory responsibilities
  • regulatory decision

  • increased regulatory
  • regulatory decisions
  • clinical science
  • innovative science
  • fda serves

  • report fda
  • fda mission
  • fda functions
  • fda gold
  • fda safety

  • fda amendments
  • beyond fda
  • bolstering science
  • speed medical
  • enhancing data

  • product innovation
  • participants discussed
  • scientific measures
  • cersi leadership
  • product protection


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