FDLI Advertising & Promotion for Medical Products Conference
Washington, DC 20036
Event summary
The Food and Drug Law Institute’s Advertising & Promotion for Medical Products Conference explored updated government agency initiatives, goals and priorities related to diversity, health equity, and trends in enforcement and regulation. The conference promoted learning, engagement and networking among regulatory and legal industry specialists. Representatives from various Food and Drug Administration (FDA) centers and other governmental agencies provided the latest information on policy, enforcement and future initiatives.
Featured agenda items
Thursday, November 2, 2023 | 11:30 am – 12:30 pm
Engaging in Pre-Approval Scientific Exchange & Business Communications
Cooley partner Elizabeth Anne Wright participated in this panel, which analyzed how we distinguish between legally sharing valuable insights and engaging in illicit FDA pre-approval communications for business gain. Panelists provided case examples and recent enforcement actions to illustrate the dos and don’ts of information exchange and address how rules differ when information is shared globally over virtual platforms and data repositories.
Friday, November 3, 2023 | 9:15 – 10:15 am
An Ode to CFL: Lessons Learned and the Path Forward
Cooley associate Wyatt Kernell participated in this panel, which provided recommendations on interpreting the 2018 guidance and warning letters concerning “consistent with FDA-required labeling” (CFL) data. Panelists shared best practices and case studies on practical considerations for implementing the guidance using real-world data and engaging in “medical, legal, and regulatory affairs review” to ensure accurate and nonmisleading advertising and promotional materials.
For more information, please email Rebecca Lanz.
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