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One-Page Patient Medication Information Document Moves Forward Under Proposed Rule

 
• By Derrick Gingery

After decades of work, the US FDA released proposed requirements for a simplified version of the Medication Guide for all products. Electronic distribution in lieu of paper ‘upon a patient’s request’ would be allowed. Comments sought on the value of consumer testing of the documents.

drug label
The FDA does not intend the new PMI document to be comprehensive. • Source: Shutterstock

Some US Food and Drug Administration-approved products may require multiple one-page patient medication information leaflets, a potential downside to the proposed regulation intended to simplify the medication guide and other consumer prescription documents.

The proposed rule, released in a 30 May Federal Register pre-publication notice, would require a one-page, clearly written summary...

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