CBER’s New Home For Gene Therapies: OTAT Changes To OTP But Leadership Questions Remain
US FDA has not named permanent heads of several offices within the new Office of Therapeutic Products, the only super office in the Center for Biologics Evaluation and Research.
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Nonclinical testing questions should be answered in a pre-IND meeting, rather than the new Type D session. A US FDA Center for Biologics Evaluation and Research official also indicated support for alternatives to animal testing when possible.
Until hiring is completed, the new Office of Therapeutic Products director must head an office and two divisions she supervises in addition to her actual duties.
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.