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Early REMS Assessments Show Room For Improvement In MedGuides

Executive Summary

Results from early Risk Evaluation and Mitigation Strategy assessments suggest sponsors have a ways to go before they can show the vast majority of patients receive, read and understand Medication Guides.

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FDA MedGuide Distribution Guidance May Mean Little Change For Manufacturers

FDA is demonstrating its intent to use discretion in enforcement with a draft guidance aimed at clarifying when Medication Guides must be distributed. However, as a practical matter, pharmaceutical manufacturers may still have to maintain their existing distribution systems for the guides.

FDA MedGuide Distribution Guidance May Mean Little Change For Manufacturers

FDA is demonstrating its intent to use discretion in enforcement with a draft guidance aimed at clarifying when Medication Guides must be distributed. However, as a practical matter, pharmaceutical manufacturers may still have to maintain their existing distribution systems for the guides.

“Defensive REMS” May Be Needed To Appease Advisory Committees

Sponsors facing an FDA advisory committee should be prepared to discuss Risk Evaluation and Mitigation Strategies, even if FDA tells a company that a REMS need only have minimal elements or is not necessary, to avoid a negative vote, industry experts say.

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