CBER’s ‘Courageous’ Coronavirus Guidance Strategy May Catch-On
Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.
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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.
Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products
The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.
The Center for Drug Evaluation and Research’s policy guru must think about the future, along with the present, in her position as director of the Office of Regulatory Policy.