Drug insert changes aim to provide clear prescribing information
Executive Briefings Digest, March 28, 2006
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The Food and Drug Administration (FDA) on January 18, 2006 released revisions to prescription drug information to give healthcare professionals more concise prescribing information.
The new package inserts will contain a highlights section providing 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.
The revisions-the first in more than 25 years-do not change the prescription drug information sheets provided to patients along with their medications, an FDA spokesperson said. All new drugs and those approved during the past five years are subject to the FDA's new information requirements.
Source: Briefings on Hospital Safety
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