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FDA's New Drug Labeling Format: Opportunity and Challenge

01 April 2006

Next Generation Pharmaceutical

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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