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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Surge of interest prompts US FDA to consider how to adjust feedback, including potentially creating a separate team to answer more basic questions.
CBER’s heavy COVID-19 workload is pushing other things to the side, causing delays in sponsor meetings and issuance of new guidance documents, and a slowdown in efforts to streamline development of individualized therapeutics, biologics center leaders tell BIO Digital 2020.
While a vaccine candidate is still months away, US FDA is already working to identify manufacturing capacity, CBER’s Peter Marks says in an interview.