Definition

Components of a REMS program that impose access restrictions, such as prescriber/pharmacy certification, patient registries, or dispensing requirements.

Example

ETASU for a teratogenic drug requires: pregnancy testing before each prescription, prescriber enrollment, pharmacy certification, and mandatory patient registry enrollment.

Regulatory source

FDA REMS Guidance

Common mistakes

Implementing ETASU without adequate infrastructure to track compliance and assess effectiveness.

Inspector question

How do you monitor ETASU compliance? What metrics do you track?

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