E2B(R3) Submission Deadline

Ensure FDA E2B(R3) mandate (April 2026) is met and handle a late upgrade.

Role: PV Operations Lead

Context: FDA E2B(R3) electronic submission is mandatory from April 2026. Your company currently submits in legacy format.

Task: Confirm readiness and correct response to inspector.

Step 1 of 2

Readiness

interview

Inspector: 'How are you meeting the FDA E2B(R3) requirement from April 2026?'

Best response?