Definition

FDA Adverse Event Reporting System; US database for adverse events. E2B(R3) electronic submission required from April 2026.

Example

Expedited and periodic submissions to FAERS in E2B(R3) format.

Regulatory source

FDA, 21 CFR 314.80, E2B(R3) mandate

Common mistakes

Missing E2B(R3) transition deadline.

Inspector question

What is your FAERS submission process and format?

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