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Format change for prescription drugs

The Food and Drug Administration has redesigned the package insert for prescription drugs to give doctors clear, precise information in priority order to reduce medical mistakes.

New and recently approved drugs must meet specific graphical requirements. Significant changes include:

• A new Highlights section at the top of the insert containing the most important prescribing information about benefits and risks, including Boxed Warning, Indications and Usage, and Dosage and Administration

• A Table of Contents for easy reference to detailed safety and efficacy information

• The date of initial product approval

• A toll-free number and Internet reporting information for suspected adverse events to encourage more widespread reporting of suspected side effects.

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