 Finally, in January 2006, the FDA released a major revision to the patient package insert guidelines, the first in 25 years.The new requirements include a section called Highlights which summarizes the most important information about benefits and risks; a Table of Contents for easy reference; the date of initial product approval; and a toll-free number and Internet address to encourage more widespread reporting of information regarding suspected adverse events.Other national or international organizations that regulate medical information include the Japanese Ministry of Health, Labour, and Welfare (MHLW).