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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US FDA's Peter Marks says the field is robust, but hedges on approval predictions for the coming years because of pandemic’s effect.
Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.
Draft guidance will help sponsor-investigators working on individualized gene therapies. The focus on basic administrative and procedural aspects of interaction with the FDA leaves many policy and commercialization questions about how these personalized investigational products should be studied unanswered.