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Session 9: FDA's Actions on the Original IND & Future Amendments
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
- FDA’s Review of an IND
- Clinical Holds: Basis for Imposition and Process for Removal