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Session 12: Special Regulatory Considerations for Development
Session Chair(s)
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, 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