Pharma News Intelligence July 7, 2020
The COVID-19 vaccine development guidance includes recommendations on chemistry, manufacturing, non-clinical data, clinical trials, safety, assays, and emergency use authorizations.
FDA recently issued guidance to assist sponsors with COVID-19 vaccine development development and licensure of their products. The guidance will be effective for the remainder of the public health emergency.
FDA first released key considerations regarding chemistry, manufacturing, and controls.
The first general consideration is that the COVID-19 vaccines licensed in the US must meet the statutory and regulatory requirements for vaccine development and approval, including for quality, development, manufacture, and control.
Additionally, COVID-19 vaccine development may be accelerated based on knowledge gained from similar products manufactured with the same well-characterized platform technology.
FDA also touched on various recommendations regarding...
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