April 1989
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Therapeutic Innovation and Regulatory Science
The process of assessing adverse experience reports in light of the need to make labeling changes is described. This process includes a comprehensive risk management program and procedures for continuously monitoring and evaluating new safety information. Label changes are a team effort including representatives from medical, regulatory, legal, and marketing disciplines. The decision to make a label change may also affect production and sales promotional campaigns. Changes in the US label may also impact requirements for professional labeling in foreign countries. A flow diagram for making a label change is provided.