Drugs and Biologics: Labeling

March 10, 2015 11:30am

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