FDA Releases Two New Serology Templates for Test Developers
New guidance on what should be submitted to the FDA in support of an EUA request or pre-EUA request for a SARS-CoV-2 antibody test.
COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration
Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.
New guidance on what should be submitted to the FDA in support of an EUA request or pre-EUA request for a SARS-CoV-2 antibody test.
Recent developments in emergency use authorizations for investigational therapies for use in the treatment of mild to moderate COVID-19.
Points of interest from the US Food and Drug Administration’s November 2020 update to investigational COVID-19 convalescent plasma guidelines.
More about the first at-home COVID-19 test, a rapid, single-use molecular diagnostic test kit for the qualitative detection of SARS-CoV-2 RNA from self-collected nasal swab specimens.
Tests of interest as part of new FDA-allowed at-home specimen collection options.
Breakout of examples of modifications that will and will not be permitted with influenza and RSV clinical lab tests during the public health emergency.
New guidance on what should be submitted to the FDA in support of an EUA request or pre-EUA request for a SARS-CoV-2 antibody test.
Recent developments in emergency use authorizations for investigational therapies for use in the treatment of mild to moderate COVID-19.
Points of interest from the US Food and Drug Administration’s November 2020 update to investigational COVID-19 convalescent plasma guidelines.
More about the first at-home COVID-19 test, a rapid, single-use molecular diagnostic test kit for the qualitative detection of SARS-CoV-2 RNA from self-collected nasal swab specimens.
Tests of interest as part of new FDA-allowed at-home specimen collection options.
Breakout of examples of modifications that will and will not be permitted with influenza and RSV clinical lab tests during the public health emergency.