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Session 2: FDA Updates – A Busy Year
Session Chair(s)
Catherine Gray, PHARMD
Director, Office of Prescription Drug Promotion, OMP, CDER , FDA, United States
Amy Muhlberg, PHD
, United States
This session will feature senior representatives from CDER, CBER and CDRH. The group will provide updates on recent FDA advertising and promotion activities, including compliance actions, process modifications, and program highlights.
Learning Objective :
- Apply lessons from recent compliance actions to current advertising and promotion review work
- Recognize significant advertising and labeling concerns that each FDA medical product Center addresses
- Recognize the broad portfolio of FDA’s activities involved in regulating medical product promotion
Speaker(s)
Catherine Gray, PHARMD
Director, Office of Prescription Drug Promotion, OMP, CDER , FDA, United States
OPDP – It’s Been A Busy Year
Kristine T. Khuc, PHARMD
Consumer Safety Officer, CBER, FDA, United States
FDA Updates in Advertising and Promotion: CBER APLB
Deborah Wolf, JD
Regulatory Counsel, OPEQ , Regulatory Policy, CDRH, FDA, United States
Evaluating Labeling and Advertising