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Session 1: A Year in Review: Guidance Documents and Enforcement 2024
Session Chair(s)
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States
This session summarizes the Office of Prescription Drug Promotion's (OPDP) enforcement actions, including an overview of all issued letters, with a focus on two oncology-related letters sent to pharma companies. It will also cover recent key policies, including the misinformation guidance and the CCN rule, emphasizing compliance risks and First Amendment considerations related to the SIUU (Scientific Information for Unsolicited Requests) guidance.
Learning Objective : - Identify the FDA's approach to advertising and promotion enforcement
- Apply lessons learned from recent enforcement actions to current advertising and promotion review
- Recognize the compliance risks and First Amendment considerations associated with SIUU communications
Speaker(s)
New Guidance and Enforcement Action for 2024
Lisa Hubbard, RPh, RAC
Opus Regulatory, Inc., United States
Principal Consultant, Regulatory Advertising and Promotion
New Guidance and Enforcement Action for 2024
Heather Banuelos, JD
King & Spalding LLP, United States
Counsel