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Session 12: Special Regulatory Considerations for Development
Session Chair(s)
Drusilla Scott, PhD, RAC
Vice President, Regulatory Affairs
Sobi, Inc., United States
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, 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
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