REMS and ETASU

Explain REMS and ETASU to an inspector (FDA).

Role: Risk Management Lead

Context: Your product has a FDA REMS with ETASU (e.g. pregnancy testing). Inspector asks how you ensure compliance.

Task: Describe programme and metrics.

Step 1 of 2

ETASU

interview

Inspector: 'What are the ETASU for this product?'

Best answer?