FDA Regional Implementation Guide for E2B(R3) Electronic Tra

This technical specifications document is to assist interested parties in electronically submitting individual case safety reports (ICSRs) (and ICSR attachments) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) in the Food and Drug Adm

Related Keywords

, Drug Administration , Guidance Issuing Office , International Conference On Harmonisation , Docket Number , Drug Evaluation , Biologics Evaluation , Event Reporting System , International Conference , Implementation Guideline ,