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- Title
Rx package inserts: Redesigned with fewer errors in mind.
- Authors
Fass, Jennifer A.; Seamon, Matthew J.; Cytacki, Jacqueline
- Abstract
The article discusses the revisions to the format for package inserts (PIs) as mandated by the U.S. Food and Drug in its new regulation issued in January 2006. According to the authors, the purpose of the new PI format is to prompt pharmaceutical firms to create an easy to understand PIs which read more like a drug information reference. They state that the PIs for newly approved drugs will now feature new sections including the Highlight, the Contents, and the Patient Counseling sections. A sample format of the revised PI is presented which highlights the changes to the document.
- Subjects
UNITED States; MEDICAL prescriptions; COMMERCIAL documents; REVISIONS; UNITED States. Food &; Drug Administration; DRUG prescription laws; PRINTING of documents; PHARMACEUTICAL industry; MEDICAL laws
- Publication
Journal of Family Practice, 2007, Vol 56, Issue 6, p438
- ISSN
0094-3509
- Publication type
Article