FDA Updates: Translational Science, MDUFA Reauthorization Discussions
FDA BRIEF: Week of May 9, 2016
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