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<a href="https://www.fiercebiotech.com/biotech/cber-chief-prasad-steps-aside-deputy-takes-reins-search-successor-continues" hreflang="en">CBER chief Prasad steps aside, deputy takes the reins as search for successor continues</a>

fiercebiotech.com·May 1, 2026

Vinay Prasad has stepped down as director of the FDA's Center for Biologics Evaluation and Research (CBER), with his deputy, Katherine Szarama, appointed as acting director while a search for a permanent successor continues. Prasad's tenure was marked by controversies, including disputes over regulatory decisions affecting gene therapies.

The departure of Vinay Prasad from the FDA's Center for Biologics Evaluation and Research (CBER) could signal shifts in regulatory approaches, especially regarding gene therapies and rare disease treatments. With Katherine Szarama stepping in as acting director, it may be a strategic moment for healthtech and biotech companies to engage with CBER to influence and understand upcoming policy directions, particularly if they are developing therapies in contentious areas like those previously affected by Prasad's tenure.

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