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

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