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Vijay Kumar, the acting director of the Food and Drug Administration's Office of Therapeutic Products — the unit that reviews cell and gene therapies for safety and approval — is leaving his post, according to an internal email obtained by STAT.
Kumar cited personal reflection and said the decision not to renew his detail was reached mutually with agency leadership.
His exit extends an already unsettled period for the Center for Biologics Evaluation and Research, the FDA division that houses his office.
What the Office of Therapeutic Products Does The Office of Therapeutic Products sits at the center of one of biotech's most consequential regulatory pipelines.
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