The US Food and Drug Administration is working to accelerate clinical development of manufactured, plasma-derived hyperimmune globulin therapeutics for COVID-19 while also enabling emergency use in seriously ill patients of raw plasma collected from donors who have recovered from the disease.
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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