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Advertising and Promotion Regulatory Affairs Conference
Session 2: FDA Update
Session Chair(s)
Wayne Pines
- President, health care
- APCO Worldwide Inc., 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
- President, health care
- APCO Worldwide Inc., United States
Considerations for Prescription Biological Reference and Biosimilar Products-Questions and Answers: Draft Guidance
Elizabeth Pepinsky, JD
- Health Science Policy Analyst
- FDA, United States
FDA Update on Oversight of Prescription Drug Promotion
Thomas W. Abrams, MBA, RPh
- Director, Office of Prescription Drug Promotion, OMP, CDER
- FDA, United States
CBER APLB
Lisa Stockbridge, PhD, MS
- Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
- FDA, United States
Introduction to Combination Products
Melissa B Burns, MS
- Senior Program Manager, Office of Combination Products, OCPP, OC
- FDA, United States
Contact us
Registration Questions?
Preconference Primer
Drug and Medical Device Ad Promo Primer
On Demand Content Preview Webinar
Ad/Promo eCTD Submissions Round Table
Additional Information
Advertising and Promotion Regulatory Affairs Resource Kit
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