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Welcome, Opening Remarks and Session 1: FDA Updates
Session Chair(s)
Catherine Gray, PharmD
Director, Office of Prescription Drug Promotion, OMP, CDER
FDA, United States
This session will feature senior representatives from FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH) and Center for Veterinary Medicine (CVM). The representatives will provide updates on recent FDA advertising and promotion activities, including compliance actions, process modifications, program areas and goals for 2022.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain the impact of OPDP’s 5-day Core Launch Review process
- Apply lessons from recent compliance actions to current advertising and promotion review work
- Identify trends in compliance activities over the last year
- Recognize significant advertising and labeling concerns that each FDA medical product Center addresses
Speaker(s)
OPDP Updates – It’s More Than Compliance
Catherine Gray, PharmD
FDA, United States
Director, Office of Prescription Drug Promotion, OMP, CDER
Speaker
Lisa Stockbridge, PhD
FDA, United States
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
Speaker
Deborah Wolf, JD
FDA, United States
Regulatory Counsel, OPEQ , Regulatory Policy, CDRH
Speaker
Kathryn Dennehy, DVM
FDA, United States
Veterinary Medical Officer, Office of Surveillance and Compliance , CVM
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