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The FDA’s capacity to evaluate new and genericdrug applications and its oversight over drug manufacturing are why we have this degree of assurance. Thousands of dedicated medical doctors, nurses, pharmacists, scientists, statisticians and other analysts are responsible for CEDR’s important work.
They inform industrial scientists what is necessary to ensure that their product meets the safety and efficacy requirements to get a product approved in humans. For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve.
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.
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