Sara Brenner was finally named the US Food and Drug Administration’s acting commissioner, per agency website updates made mid-day 24 January, after several days of wondering who is running the agency.
FDA Transition: New Acting Commissioner, Disappearing Docs, Scientific Publication Freeze
The FDA's interim leadership takes shape, but the sense of transition chaos still lingers.
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In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.
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Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.
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FDA Commissioner Martin Makary declared during an interview with former Fox News host Megyn Kelly that there “should be nothing political” about the US FDA, but it feels like politics is infecting the agency in unprecedented ways about three weeks into his tenure.
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Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.
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Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.
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Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.
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Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.