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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
Deputy Director, OPDP’s Division of Promotion Policy, Research and Operations
FDA, 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)
OPDP – It’s Been A Busy Year
Catherine Gray, PharmD
FDA, United States
Director, Office of Prescription Drug Promotion, OMP, CDER
FDA Updates in Advertising and Promotion: CBER APLB
Kristine T. Khuc, PharmD
FDA, United States
Consumer Safety Officer, CBER
Evaluating Labeling and Advertising
Deborah Wolf, JD
FDA, United States
Regulatory Counsel, OPEQ , Regulatory Policy, CDRH
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