REGULATORY UPDATE: FDA’s Nicole Verdun Placed on Administrative Leave

Nicole Verdun, MD, director of the Office of Therapeutic Products (OTP) within the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER), has been placed on administrative leave, according to a report by STAT News. Rachael Anatol, PhD, deputy director of OTP, was also placed on leave.

Verdun joined FDA in 2012 and previously led the Office of Blood Research and Review (OBRR) before becoming director of OTP upon its establishment in 2023. The new office was created through a reorganization of the former Office of Tissues and Advanced Therapies to address the increasing complexity and volume of cell and gene therapy (CGT) products.

Under Verdun’s leadership, OTP has taken steps to modernize its approach to CGT development, including increasing the agency’s review capacity and enhancing engagement with product sponsors.

AABB Statement

At OBRR and OTP, Verdun was a respected leader and consistent resource for the AABB community. A regular presence at the “Ask the FDA” session during the AABB Annual Meeting, she frequently engaged with AABB’s Regulatory Affairs team and Transfusion Transmitted Diseases Committee to help the blood and biotherapies field navigate FDA requirements, share updates on guidance and policy initiatives, and support open dialogue between the agency and stakeholders.

“AABB is grateful to Dr. Verdun for her years of service and dedication to advancing the field of blood and biotherapies,” said Sharon Carayiannis, MT(ASCP)HP, AABB’s vice president, accreditation, standards and quality. “Her consistent engagement with our community has been instrumental in strengthening communication between FDA and AABB members, and patient care is better today thanks in no small part to her expertise and leadership.”