US FDA’s Top Two Vaccine Officials Announce Surprise Retirements
Departures of Marion Gruber and Philip Krause may stem from White House and CDC actions related to the COVID-19 vaccines.
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CBER Director Marks’ Intervention On Sarepta Gene Therapy Filing Decision Appears To Backfire
Former OTAT Director Wilson Bryan says Peter Marks’ order to file Sarepta’s DMD gene therapy application was mainly a public relations move, which does not seem to have worked in the FDA’s favor. Upcoming advisory committee could now involve as much scrutiny of the agency as the application itself.
The Risk-Reward Of US FDA Leadership Running Offices Below Them
CBER’s Celia Witten is the latest senior executive to run an office within the center during a leadership transition, a move that can help achieve specific goals, but also create tension.
US FDA’s Marks Was Frustrated About Slow Completion Of 2021 Comirnaty Review
CBER Director Peter Marks told Janet Woodcock in an email that he thought reviewers were treating the BLA for the first fully approved COVID-19 vaccine as a conventional review or learning exercise.