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Session 9: How to Apply the CFL Guidance: References and Disclaimers
Session Chair(s)
Micheline Awad, MBA
Sr. Director, Regulatory Advertising, Promotion, and Labeling
Day One Biopharmaceuticals, United States
This session will focus on applying the CFL guidance to various data presentations in promotional materials. You will learn how to effectively collaborate with various colleagues across your organization to properly disclose and support CFL content for various types of analyses/data such as sub-group analyses, post-hoc analyses, and long-term follow up trials (pivotal or other). Using examples, the panel will provide an interactive learning experience to help drive the conversation and help you to determine the appropriate level of evidentiary support and disclaimers needed to support claims, in accordance with the CFL guidance.
Learning Objective : At the conclusion of this session, participants should be able to:
- Examine FDA’s perspective on appropriate use of references
- Evaluate the potential evidentiary support for different types of claims and responsibilities
- Apply disclaimers & disclose material information for CFL content
Speaker(s)
Speaker
Glenn N. Byrd, MBA
GByrd Ad-Promo Solutions, LLC, United States
President
Speaker
Linda Kollmar, MD
Merck & Co., Inc., United States
Executive Director, Team Lead Medical Consult and Review Physicians
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