Gene Therapy May Pack US FDA’s Calendar This Fall; CBER Staffs Up
Just as COVID-19 work begins to wane, CBER’s Peter Marks expects an influx of gene therapy work as sponsors attempt to salvage clinical trials.
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Center for Biologics and Evaluation and Research is to resume normal operations at the beginning of 2023 and will stop prioritizing resources for COVID-19 regulatory work over non-COVID-19 matters.
Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.
Surge of interest prompts US FDA to consider how to adjust feedback, including potentially creating a separate team to answer more basic questions.