Digital IND Safety Reporting - Pharmacovigilance 2020

Meredith K. Chuk, M.D., Acting Associate Director for Safety, Office of Oncologic Diseases, CDER, provides a background and implementation plans for digital investigational new drug (IND) safety reporting. She describes the process, data flow, types of IND safety reports to be sent to FAERS, and data elements for IND safety reports using ICH E2B(R2).
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