FDA Publish Guidance on Risk Evaluation & Mitigation Strategies (REMS)
This guidance is intended to address two topics pertaining to Medication Guides for drug and biological products:
• When FDA intends to exercise enforcement discretion regarding when a Medication Guide must be distributed with a drug or biological product dispensed to a healthcare professional for administration to a patient4 instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient.
• When a Medication Guide will be required as part of a risk evaluation and mitigation strategy (REMS).
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