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FDA Proposes Streamlined Medication Handouts

June 5, 2023


After more than a decade of debate and discussion, FDA has published a new system for providing basic and essential information on patient use of drugs and certain biologic products. A new one-page Patient Medication Information (PMI) guide would replace the more complex and lengthy Patient Package Inserts (PPIs) now distributed in pharmacies dispensing prescription medicines.

The aim of the new program is to reduce drug misuse and adverse reactions by providing accurate information on product indications and uses to help people take prescription medicines safety and effectively, stated FDA Commissioner Robert Califf in unveiling the new proposal May 30, 2023. Currently, the different types of information on prescription drugs as now required can be confusing and prompt patients to stop taking medications or to use them inappropriately, leading to treatment failures, hospitalizations and even deaths.

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