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NCPA recently submitted comments to the FDA on its proposed rule titled “Medication Guides: Patient Medication Information.” The proposed rule would require manufacturers to create a one-page document, called Patient Medication Information (PMI), that would replace the current Medication Guides, Patient Package Inserts and Consumer Medication Information that are distributed to patients.
Antiseizure drugs levetiracetam and clobazam can cause a serious hypersensitivity reaction called drug reactions with eosinophilia and systemic symptoms (DRESS), the FDA said.
/PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a drug...
On May 31, FDA proposed a change to standardize and consolidate prescription drug product labels into patient guides with essential medication information on safe use.
Proposed Patient Medication Information (PMI) is the latest in many efforts by FDA to mandate patient-directed labeling Last week, the U.S. Food and…