US FDA To Exercise ‘Maximum Regulatory Flexibility’ For COVID-19 Plasma-Derived Therapeutics
Agency is working with manufacturers, including Takeda and Emergent BioSolutions, to accelerate development of hyperimmune globulin products, with an eye toward starting clinical testing in several months; new FDA guidelines on convalescent plasma collection for single-patient emergency IND use are helpful in understanding agency expectations around source plasma collection for manufactured products as well, Emergent SVP Laura Saward says.
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US FDA authorization will further boost already-high demand for plasma from individuals recovered from COVID-19 and increase competition for donors, NYU’s Arthur Caplan predicts, but CoVIg-19 Plasma Alliance and Emergent BioSolutions say they do not expect EUA to impact either product supply or enrollment in upcoming randomized trials of their H-Ig products.
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.
The agency prefers traditional clinical trials be used, but will also allow expanded access or single-patient emergency INDs for the potential coronavirus treatments.