In vitro diagnostics, or IVDs, have a somewhat unique position among the gamut of products that the Food and Drug Administration (FDA) oversees and regulates on behalf of the U.S. public. IVDs are ...
Industry voiced several complaints during agency’s comment period and provided some evidence of negative consequences. Biopharma businesses and industry groups joined diagnostic makers and clinical ...
Among potential changes is that manufacturers will have to anticipate customers’ intended use of their IVD products. The FDA can expect an earful from groups representing diagnostic makers and ...
A review found rheumatic conditions cause 22.2% of global cases of fever and inflammation of unknown origin. Rheumatic conditions are a common cause of fever of unknown origin (FUO) and inflammation ...
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