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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After years where many more applications received priority assessments than standard assessments, in FY 2022 the difference narrowed.
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.