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Guidance Documents/Guidance-Document/Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)

Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

November 18, 2011

April 24, 2020

Center for Drug Evaluation and Research

98ea9f8c-10ac-4377-ab9a-00ed4effd585

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