FDA Issues Long-Awaited Prescription Drug Labeling Regulations

On January 24, 2006, the FDA formally issued its long-awaited prescription drug labeling regulations, as well as draft and final guidance documents further describing the implementation of certain aspects of those regulations. FDA’s final regulations, which were issued as proposed regulations in December 2000, are part of FDA’s ongoing initiative to manage product risks and reduce adverse events by providing physicians with a simplified format to communicate risk information to patients. The Prescription Drug Labeling Regulations are the first major revisions to the Agency’s labeling regulations in over 25 years.

Click here to view the presentation prepared by John Fleder and Kurt Karst.

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