返回 Agenda
Session 7: Intersection of Labeling and AdPromo - OPDP and Industry Perspectives
Session Chair(s)
Kathleen Klemm, PHARMD, MS, RAC
Acting Director, DAPR1
FDA, United States
Georgina Lee, PHARMD
Executive Director, Global Regulatory Labeling, Advertising and Promotion
Disc Medicine, United States
Product labeling negotiations between sponsors and FDA can shape the final language in the approved label that will be used as the basis for promotion. This session will explore the general process for labeling negotiations and how advertising and promotion expertise can be applied from the industry perspective and the role of OPDP during labeling review from the FDA perspective.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the general process for FDA labeling negotiations during the review cycle
- Apply advertising and promotion expertise to support labeling development
- Explain the role of OPDP during product labeling review with sponsors
Speaker(s)
Speaker
Georgina Lee, PHARMD
Disc Medicine, United States
Executive Director, Global Regulatory Labeling, Advertising and Promotion
Speaker
Kathleen Klemm, PHARMD, MS, RAC
FDA, United States
Acting Director, DAPR1