Drugs and Biologics: Labeling
Alan G. Minsk
Arnall Golden Gregory LLP
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