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By CDER, FDA-approved patient information, for selected prescription drugs that pose a serious and significant public health concern. Medication Guides will be required if the FDA determines that one or more of the following circumstances exist: patient labeling could help prevent serious adverse effects; the drug product has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients’ decision to use, or to continue to use, the product; the drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.

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