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Guidance on Medication Guides and REMS

11/18/2011

Federal Register Notice: FDA is making available a guidance, Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS). It addresses two topics on Medication Guides for drug and biological products: (1) when FDA intends to exercise enforcement discretion as to when a Medication Guide must be provided with a drug or biologic that is dispensed to a health care professional for administering to a patient instead of being dispensed directly to the patient for self-administration or to the patient’s caregiver for administration to the patient; and (2) when a Medication Guide will be required as part of a REMS. To download this guidance, click here. To view this notice, click here.

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