FDA Publishes Draft Guidance on Medication Guides in Risk Evaluation and Mitigation Strategies

The Food and Drug Administration (FDA) recently published a draft guidance for industry titled Medication Guides—Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS) (Draft Guidance). The document addresses when a medication guide must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient instead of being dispensed directly to the patient or to the patient’s caregiver. The Draft Guidance also clarifies when a medication guide will be required as part of a REMS.

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