FDA's New Drug Labeling Format: Opportunity and Challenge

For the first time in more than 25 years, the FDA is overhauling the format and content of prescription drug labels. Since the 1970s, drug labels - often referred to as the package insert - have expanded in length, detail, and complexity. FDA concluded that the increasingly cluttered label hampered communication of risk information and suffered from 'over-warning' of clinically insignificant and often unsubstantiated risks.


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