Final Guidance Clarifies Distribution Requirements For MedGuides

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...