Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Lorrie McNeill
Director
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Lorrie McNeill is the director of the Office of Communication, Outreach and Development (OCOD) in FDA’s Center for Biologics Evaluation and Research. Prior to becoming Office director, she was the director of the Division of Communication and Consumer Affairs in CBER/OCOD. She has been with the Center since 1992, and with the FDA since 1990. Before joining the FDA, she worked as a public health advisor for the Centers for Disease Control and Prevention in Atlanta and Baltimore. She holds a BA degree in industrial relations from the University of North Carolina at Chapel Hill.
Abstract
Lorrie McNeill, Director of CBER’s Office of Communication, Outreach and Training (OCTHT), presents an overview of the office’s structure, roles, and commitment to communication and transparency supporting CBER’s public health mission. OCTHT, one of eight offices in CBER, is comprised of three divisions. The Division of Communication and Consumer Affairs (DCCA) handles thousands of inquiries annually from consumers, patients, and healthcare providers, leads media relations and public outreach, oversees CBER’s website and social media, and addresses misinformation. The Division of Disclosure and Oversight Management (DDOM), the largest division, manages responses to Congress and oversight bodies, processes Freedom of Information Act (FOIA) requests and related litigation (including very high volume cases), and conducts proactive disclosure analysis for website postings and international information exchanges. The Division of Manufacturers Assistance and Training (DMAT) assists thousands of inquiries each year from regulated industry and sponsors, facilitates industry liaison meetings, and manages CBER staff training, career development, and technical training programs. The office strives to provide outstanding customer service and ensure all communications support CBER’s mission with clear, factual information.