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Session 1: Inside the Agencies: A Fireside Chat on Promotion, Compliance, and Consumer Protection
Session Chair(s)
Twyla Mosey, PharmD, RPh
Division Director
FDA, United States
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States
This interactive fireside chat brings together leaders from various agencies to share perspectives on the evolving regulatory and enforcement landscape for prescription drug promotion and advertising. Panelists will discuss key areas of interagency collaboration, current enforcement priorities, and the implications for industry practices in promotion, compliance, and consumer protection. The conversation will explore how each agency approaches advertising review, substantiation standards, and risk mitigation in an increasingly complex environment. Attendees will gain practical insights to anticipate enforcement trends and strengthen their internal compliance and review frameworks.
Learning Objective : - Identify three emerging regulatory or enforcement priorities discussed by various agencies, and summarize their impact on prescription drug advertising and promotion practices
- Compare the differing approaches and areas of overlap among the four agencies
- Evaluate how interagency coordination influences enforcement outcomes and apply this understanding to refine risk assessment and escalation processes within attendees’ organizations
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