Nicole Verdun, who had been running the CBER Office of Blood Research and Review, now is director of the center’s Office of Therapeutic Products. She will manage OTP’s growing head count, as well as its increasing workload.
The new chief of the US Food and Drug Administration’s gene therapy section was taken from a nearby office within the agency.
Nicole Verdun, the head of the Center for Biologics Evaluation and Research’s Office of Blood Research and Review, has been...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
