January 2006 Revisions
The patient package insert issue was revisited in 1980 and in 1995 without conclusive action being taken. 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.
Read more about this topic: Package Insert
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