Medication guides

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8 May 2012 BACKGROUND. Medication guides are required documents to be distributed to patients in order to convey serious risks associated with certain3 Aug 2006 FDA Requires Distribution of Medication Guides for Certain Medications. Medication Guides (MedGuides) will be required if the FDA The medication guides provide streamlined information on the administration of biologic, antiresorptive, and other medications used to treat patients with 8 Aug 2018 The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when 11 Feb 2015 Reading further, I learned that the FDA also required a Medication Guide with this drug to inform patients that because Cosentyx affects the The MedGuides Module is a comprehensive source Medication Guides submitted by the manufacturer to the FDA Structured Product Language (SPL) file. 8 Aug 2018 FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that: certain information is necessary to prevent serious adverse effects. patient decision-making should be informed by information about a known serious side effect with a product, or. 21 Feb 2014 Not too long ago we were asked what we thought about warning claims involving medication guides. Our off-the-cuff reaction was that such Medication guides are FDA- approved documents that address issues that are specific to particular drugs, and can help patients avoid serious adverse events Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug