Medication package insert

The first patient package insert required by the FDA was in 1968, mandating that isoproterenol inhalation medication must contain a short warning that excessive use could cause breathing difficulties.

[citation needed] 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).

In the United States, the Prescribing Information for thousands of prescription drugs are available at the DailyMed website, provided by the National Library of Medicine.

[6] South Africa has taken the initiative of making all package inserts available electronically via the internet, listed by trade name, generic name, and classification, and Canada is working on a similar capability.

[citation needed] Patient information is, understandably, usually generated initially in the native language of the country where the product is being developed.