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E&L testing is performed to substantiate that packaging materials will not contaminate the drug product over a product’s shelf life. The FDA’s CDRH (Center for Devices and Radiological Health) branch would own the filing in this case. These compounds thus become a part of the drug matrix.
WHO chief scientist, Soumya Swaminathan also expressed extreme skepticism of the new treatment’s benefits, stating that so far, there is little evidence to support the use of convalescent plasma for the treatment of COVID-19 infected patients. Drugs and Vaccines.
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