Elements to Assure Safe Use (ETASU)

Elements to Assure Safe Use(ETASU)

Risk Management

FDA REMS component: mandatory elements to ensure safe use (e.g., training, testing).

ETASU: pregnancy test before each prescription.

FDA REMS

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Elements to Assure Safe Use(ETASU)

Risk Management

FDA REMS component: mandatory elements to ensure safe use (e.g., training, testing).

ETASU: pregnancy test before each prescription.

FDA REMS