FDA BRIEF: Week of May 9, 2016

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Director’s Corner Podcast – Talking Translational Science

Overview of translational science and how it can speed development and review of innovative new therapies

  • Translational science: Activities to translate discoveries in  laboratory to human products
  • Drug development hampered without appropriate translational science assessments
  • Example: Rare Disease Drug Development requires Natural History studies to adequately design clinical studies
  • CDER Programs : Biomarker Qualification Program, Critical Path Innovation Meetings etc.



Discussion on:

  • Pre-Submissions: Performance projections, options to address growing inventory
  • De Novo Requests: FDA resource constrained to complete reviews in a timely manner; options to reduce working inventory, achieve stability, improve performance
  • Patient Input: Potential deliverables and metrics, selection process, governance, participation  rules for user fee-funded public-private projects
  • Quality Management: Feedback from AdvaMed, MDMA, MITA
  • Workload Adjustment: Description of components, submission types, review efforts, scenarios
  • Real World Evidence: Potential deliverables, metrics, governance models, data sharing
  • Digital Health: Previous proposal, potential deliverables and metrics
  • Third Party Premarket Review: Previous proposal, potential deliverables and metrics

Next Steps: Industry to provide counter proposals at next negotiation meeting






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