Julie Schindel

Jun 7, 2023 | lexology.com | Meredith Manning |Heidi Forster Gertner |Lauren Colton |Julie Schindel |Bryan Walsh

Proposed Patient Medication Information (PMI) is the latest in many efforts by FDA to mandate patient-directed labelingLast week, the U.S. Food and Drug Administration (FDA) published the proposed rule “Medication Guides: Patient Medication Information,” which would significantly change the agency’s prescription drug product labeling regulations to require that Rx drug and biological product applicants create a new type of Medication Guide, called the Patient Medication Information (PMI).