The labeling of the drug/biologic is the final stage of the approval process. The label controls what you can do post-approval and as such it is the point of transition between the approval process and post-approval world.

• Labeling overview: key regulatory requirements, information, and contents
• Exploring the review process for labeling
• Incorporating clinical trial data on the label
• Appreciating the influence of final labeling on the scope of post-market activities
• Amending labeling post-marketing
• Using labeling as a defense in products liability litigation
• Exploring label carve outs and the 2024 Novartis v. FDA case
  • Discussing the requirements for skinny and narrow labeling