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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The request from House Energy and Commerce Committee Republicans states they are worried about retaliation against career agency staff.
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.