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Final Guidance Clarifies Distribution Requirements For MedGuides

 
• By Cathy Dombrowski

Final policy on distribution of Medication Guides and inclusion in Risk Evaluation and Mitigation Strategies makes clear what FDA considers a material change.

One exception to FDA’s new policy of reducing requirements to disseminate Medication Guides is if there is a material change to the MedGuide, such as a new indication or new safety information, according to the agency’s final guidance.

“Medication Guides – Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)” explains how FDA will use discretion...

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