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The Food and Drug Administration (FDA) has named Katherine Szarama to be the acting director of the unit in charge of regulating vaccines and other biological products for human use. An official for the Department of Health and Human Services (HHS) confirmed to The Hill that Szarama will take over the role from Vinay
Food and Drug Administration has named Katherine Szarama as the acting director of its vaccines and biologics unit, Politico reported on Thursday, after Vinay Prasad's turbulent tenure came to an end this week.
The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.
FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.
Katherine Szarama, who joined the FDA last year to serve as Vinay Prasad’s deputy, will now fill his shoes at CBER.
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The decision also marks the FDA’s first approval of a PROTAC therapy, a type of targeted protein-degrading drug. ・The approval is based on a Phase 3 trial, in which Veppanu reduced the risk of disease progression or death by 43% compared with Fulvestrant.