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FDA Draft Guidance Urges Consistency, Plain Language In Combo Product Instructions

 
• By Elizabeth Orr

A new draft guidance document from the US agency offers nuts-and-bolts guidance on formatting Instructions for Use (IFUs) for drug-device and biologic-device combination product applications.

Drugstore customer
An IFU is a component of combination product labeling that helps consumers access treatment

Instructions for Use (IFUs) for combination products should use clear, concise and nontechnical language whenever possible to help ensure they’re useful to patients, the US Food and Drug Administration says in a new draft guidance that includes specific wording recommendations.

The 20-page document applies to drug-device and biologic-device products that are submitted to the FDA under a new drug application...

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