Electronic Submission of Adverse Event Reports to FAERS using ICH E2B(R3) Standards - Oct. 11, 2019

Suranjan De from CDER’s Office of Surveillance & Epidemiology discusses plans, progress, and technical specifications on enhancements to electronic submission of premarket and post-market Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards.

Find more information at https://www.fda.gov/drugs/cder-small-...

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