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Part 4
Session Chair(s)
Elliott Berger, PHD, MS
President
ETB Regulatory Consulting, United States
The IND In Detail - Additional Topics
- Additional Requirements for Biologics and Biotechnology-derived Products
- Assembly and Submission of an Original IND
- Amendments to the IND
- Annual Reports
- Non-standard INDs
- IND Administrative Actions
- Special Protocol Assessment
- Special Development Pathways
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