Good article about the new labeling process from Medscape, subscription may be required..BD 

For the first time in over 25 years, the Food and Drug Administration (FDA) has revised the content and format of prescription drug labeling to give health care practitioners prescribing information that is clearer and more concise. Changing several features of the labeling makes it easier to read and draws attention to the most important drug information prior to prescribing. The initiative stems from a new FDA final rule," Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," which became effective on June 30, 2006.[1-3] This final rule is part of FDA's strategic initiative to manage the risks of medical product use and minimize adverse events involving the products it regulates.

Introduction to the New Prescription Drug Labeling by the FDA

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