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.
See the main story that goes with this sidebar: Uniformity bill moves forward
