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Advertising and Promotion Regulatory Affairs Conference

This event is now offered in a new entirely virtual format.


Session 2: FDA Update

Session Chair(s)

Wayne  Pines

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)

Wayne  Pines

FDA Update

Wayne Pines

  • President, health care
  • APCO Worldwide Inc., United States
Elizabeth  Pepinsky, JD

Considerations for Prescription Biological Reference and Biosimilar Products-Questions and Answers: Draft Guidance

Elizabeth Pepinsky, JD

  • Health Science Policy Analyst
  • FDA, United States
Thomas W. Abrams, MBA, RPh

FDA Update on Oversight of Prescription Drug Promotion

Thomas W. Abrams, MBA, RPh

  • Director, Office of Prescription Drug Promotion, OMP, CDER
  • FDA, United States
Lisa  Stockbridge, PhD, MS

CBER APLB

Lisa Stockbridge, PhD, MS

  • Branch Chief, Advertising and Promotional Labeling Branch, OCBQ, CBER
  • FDA, United States
Melissa B Burns, MS

Introduction to Combination Products

Melissa B Burns, MS

  • Senior Program Manager, Office of Combination Products, OCPP, OC
  • FDA, United States

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