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SESSION 7: FDA’S ACTIONS ON THE ORIGINAL IND & FUTURE AMENDMENTS
Session Chair(s)
Carol H. Danielson, DrPH, MS, RAC
President
Regulatory Advantage, LLC, United States
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, United States
- FDA's review on an IND
- Clinical Holds: Basis for imposition and process for removal
- Administrative actions
Speaker(s)
FDA’S ACTIONS ON THE ORIGINAL IND & FUTURE AMENDMENTS
Carol H. Danielson, DrPH, MS, RAC
Regulatory Advantage, LLC, United States
President
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