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Session 3: The IND in Detail - Items 1-6
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
- IND Item 1: Form FDA 1571
- IND Item 2: Table of Contents
- IND Item 3: Introductory Statement
- IND Item 4: General Investigation Plan
- IND Item 5: Investigator’s Brochure
- IND Item 6: Protocols
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