FDAnews Drug Daily Bulletin

FDA TO COHOST WORKSHOP ON IMPLEMENTING FINAL RULE ON PRESCRIPTION DRUG LABELING

April 14, 2006
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The FDA will cohost a workshop in May that aims to help drugmakers implement broad new requirements for pharmaceutical product labeling.

The agency and the Drug Information Association (DIA) have scheduled the hands-on workshop May 4-5 on the final rule for prescription drug labeling content and format. FDA speakers will present the new requirements and provide an overview of general principles for converting labeling to the new format, as described in draft implementing guidance released in January, the FDA said.

The labeling initiative is designed to reduce medical errors by presenting the information in an easier-to-read package insert. Under the final rule, the FDA requires drugmakers to include a "highlights" section in the insert explaining the most important information about a drug, including health warnings, indication and usage, and dosage and administration requirements.

Participants in the workshop will practice converting labeling from the "old" to the "new" format in small-group, hands-on sessions led by FDA staff.

For more information, access http://www.diahome.org/product/11144/06024.pdf (http://www.diahome.org/product/11144/06024.pdf).