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FDA mandates drug information update

Pharmacy Regulation Resource, January 26, 2006

The FDA on January 18 released revisions to prescription drug information to give healthcare professionals more concise prescribing information, the agency said in a press release.

The new package inserts will contain a highlights section to provide immediate access to the most important information about a drug's benefits and risks. A table of contents will provide reference for detailed safety and efficacy information.

The insert will also contain the date of the initial product approval, allowing healthcare practitioners to determine how long the product has been on the market.

A toll-free number and Internet reporting information on the insert will give practitioners quick access to channels allowing them to report suspected adverse events involving the medication, the FDA said.

The revisions to the prescription information are the first in more than 25 years.