CBER Reorganization Aims To Fight Recruitment Challenges, Tackle Upcoming Gene Therapy Wave
A growing focus on real-world evidence and an expected infusion of user fee funding are among the reasons for the new office branches at US FDA’s biologics center.
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Standardizing the process for providing clarifications following sponsor meetings, particularly with regard to the written response-only format, is one of several solutions being piloted by the Office of Tissues and Advanced Therapies as part of its ‘growth program,’ which aims to expedite advances in cell/gene therapies while also improving staff satisfaction.
As decisions on additional boosters and childhood inoculations loom, CBER Director Peter Marks is still heading the vaccines division on an acting basis since the departures of Marion Gruber and Philip Krause last year. Who might succeed them?
Outside the pandemic, sponsor INDs for investigational cell and gene therapies appear to be driving much of the increase, and the surging growth continues to cause workload challenges for the US FDA.