The heavy COVID-19 workload for the US Food and Drug Administration’s biologics center is delaying sponsor meetings and new gene therapy guidances, as well as slowing efforts to streamline development of individualized therapeutics.
US FDA’s Gene Therapy Work Feeling The Effects Of Pandemic Response
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.
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