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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)
FDA Update
Wayne Pines
United States
President, Health Care
Considerations for Prescription Biological Reference and Biosimilar Products-Questions and Answers: Draft Guidance
Elizabeth Pepinsky, JD
FDA, United States
Health Science Policy Analyst
FDA Update on Oversight of Prescription Drug Promotion
Thomas W. Abrams, MBA, RPh
Former FDA, United States
Retired, Director, Office of Prescription Drug Promotion, OMP, CDER
CBER APLB
Lisa Stockbridge, PhD
FDA, United States
Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
Introduction to Combination Products
Melissa Burns, MS
FDA, United States
Senior Program Manager, Office of Combination Products, OCPP, OC