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SESSION 10: SPECIAL REGULATORY CONSIDERATIONS FOR DEVELOPMENT
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
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
Speaker(s)
SPECIAL REGULATORY CONSIDERATIONS FOR DEVELOPMENT
Carol H. Danielson, DrPH, MS, RAC
Regulatory Advantage, LLC, United States
President
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