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Questions and Answers on Guidance for Industry: Medication Guides - Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)

Q1. Why did FDA publish a draft guidance on Medication Guides?

A. FDA published a draft guidance on Medication Guides because the Agency has received comments from healthcare professionals and drug companies saying that they were confused about when they were supposed to distribute a Medication Guide in inpatient and outpatient settings where drugs...

[Link to FDA Q&A page]