Back To Normal? US FDA Schedules In-Person Meeting But Pauses Non-COVID Guidance Development
As the agency and country plot the steps to reopening, a full resumption of activities still seems a long way off.
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Director Peter Marks says faster guidance development practices produced well-written documents and may be adopted once the pandemic ends.
Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.
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.