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.
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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 former Emory professor is now leading the US FDA Division of Hepatology & Nutrition after its inaugural director, Joseph Toerner, moves back to the infectious disease field as acting deputy in FDA’s vaccines office.
Transformation of former Office of Tissues and Advanced Therapies into a ‘super office’ will provide leadership opportunities for a younger generation, retiring director Wilson Bryan says. CBER head Peter Marks says he is not concerned if agency staff later go to work for industry; suggests increased staffing and reorg could help cut down on gene therapy IND clinical holds.