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Session 12: Special Regulatory Considerations for Development
Session Chair(s)
Elliott Berger, PhD, MS
President
ETB Regualtory Consulting, United States
- Special Protocol Assessment
- Special Development Pathways
- Subpart E (expedited drug development)
- Subpart H (accelerated approval)
- Fast track
- New pathways under FDASIA
- Breakthrough therapy
- Qualified infectious disease product
- Orphan Products