(For Biologics) The measure of the biological activity using a suitably quantitative biological assay, based on the attribute of the product which is linked to the relevant biological properties.
(For Biologics) The measure of the biological activity using a suitably quantitative biological assay, based on the attribute of the product which is linked to the relevant biological properties.
An adverse event related to the use of a medical device. This definition includes any…
View definitionAn important identified risk, an important potential risk, or important missing information.
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