On May 31, the U.S. Food and Drug Administration (FDA) published a proposed rule to amend its regulations regarding prescription drug product labeling regulations.[1] Under the new rule, each time a prescription drug products is used, dispensed, or administered in an outpatient setting, the patient would receive a one-page “Patient Medication Information” (PMI) Medication Guide that highlights essential information regarding the use of the drug. If implemented, FDA believes this rule will consolidate the various forms of prescription information that are dispensed to patients and consequently alleviate confusion for manufacturers deciding what forms are needed with particular prescriptions. Overall, it appears that the FDA’s goals are twofold: (1) standardization of patient-facing prescription drug product labeling, and (2) to expand accessibility of essential safety and efficacy information relevant to such medications.Continue Reading FDA Issues Proposed Rule for Standardized and Accessible Patient Medication Information