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FDA’s top gene therapy regulator is leaving his role

Vijay Kumar, the FDA's lead official for cell and gene therapy, is stepping down after one year in the role.

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The brief

The acting director of the FDA’s cell and gene therapy division, Vijay Kumar, is departing from his leadership position. The move comes exactly one year after he assumed the role at the agency.

Coverage from BioSpace, Endpoints News, BioPharma Dive, Fierce Biotech, and STAT News confirms the leadership change. These outlets focus on the timing of his resignation and his specific oversight of the gene and cell therapy portfolio.

It remains to be seen who will be appointed to fill the vacancy created by his departure. Details regarding a permanent replacement or an interim successor have not been specified.

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Quick answers

Who is leaving the FDA?

Vijay Kumar, the acting director of cell and gene therapies, is leaving his position.

How long was the regulator in his role?

He served in the role for one year.

Has a successor been named?

Coverage does not yet specify who will replace him.

Coverage (6)

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