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US FDA’s Gene Therapy Work Feeling The Effects Of Pandemic Response

 
• By Sue Sutter

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.

Mobile Electronic Traffic Sign stating “expect Delays” taken at sunset with traffic blurred driving past the sign and traffic cones
US FDA's policy work in the gene therapy space has been delayed by the need to respond to the coronavirus pandemic. • Source: Shutterstock

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.

In separate sessions at the Biotechnology Innovation Organization’s virtual annual meeting, Center for Biologics Evaluation and Research director Peter Marks and CBER Office of Tissues and Advanced Therapies director Wilson Bryan said that while addressing the novel coronavirus

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