FDA unveils long-awaited Patient Medication Information proposed rule

Since 2017, the FDA has been working on a proposal to create a new type of patient-focused labeling for certain outpatient drug products that would be specifically targeted for patient use. That proposed rule, which would establish Patient Medication Information (PMI) as a type of labeling, has now been published. But while the rule emphasizes a brief, patient-friendly approach, drug and biologics companies may find the proposal difficult to operationalize.

Regulatory background and context

The FDA uses various controls, including labeling and warnings, to ensure that medical products are used appropriately and safely.

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