The labeling of the drug/biological product is the final stage of the approval process. The labeling affects what you can do post-approval. It is the point of transition between the approval process and post-approval world.

• Labeling overview: key regulatory requirements, information, and contents
• Review process for labeling
• How does the final labeling control the scope of post-market activities?
• How can and when should the labeling be amended post-market?
• How is the labeling a defense in products litigation?
• When can punitive damages may be rewarded with respect to labeling
• Assessing the impact of labeling on reimbursement