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Session 2: FDA Update
Session Chair(s)
Wayne Pines
President, Health Care, United States
This session, organized by senior representatives from the three FDA medical centers, will provide a summary of recent enforcement and actions taken in the ad promo area. This session will also present a perspective on the enforcement priorities and concerns of the FDA centers, recent guidance issued, and the guidance’s being developed.
Learning Objective :
At the conclusion of this session, the participant should be able to:
- Understand better the recent ad promo enforcement actions, what motivated the agency to take enforcement action on that particular alleged violation
- How the agency is viewing enforcement
- What issues arise from the latest guidances and general policy evolution
Speaker(s)
Wayne Pines
President, Health Care, United States
FDA Update
Elizabeth Pepinsky, JD
Health Science Policy Analyst, FDA, United States
Considerations for Prescription Biological Reference and Biosimilar Products-Questions and Answers: Draft Guidance
Thomas W. Abrams, MBA, RPH
Retired, Director, Office of Prescription Drug Promotion, OMP, CDER, Former FDA, United States
FDA Update on Oversight of Prescription Drug Promotion
Lisa Stockbridge, PHD
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER, FDA, United States
CBER APLB
Melissa Burns, MS
Senior Program Manager, Office of Combination Products, OCPP, OC, FDA, United States
Introduction to Combination Products
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