FDA Issues Four New Warning Letters for Adulterated and Misbranded COVID-19 Tests
The four companies implicated in recent FDA warning letters over unauthorized COVID-19 tests. What did these tests have in common?
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.
The four companies implicated in recent FDA warning letters over unauthorized COVID-19 tests. What did these tests have in common?
Update on emergency use authorization for third SARS-CoV-2 POC antigen test.
What the National Cancer Institute (NCI) found toward the revocation of Autobio Diagnostics’ antibody test EUA.
New developments in measuring SARS-CoV-2 antibodies.
Overview of new CMS resource for understanding SARS-CoV-2 antigen test distribution to nursing homes.
FDA guidance provides pathway for developers and manufacturers to obtain EUAs for at-home and over-the-counter COVID-19 testing. The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) template for test developers attempting to create at-home and over-the-counter SARS-CoV-2 diagnostic tests. The FDA announced this new template in
The four companies implicated in recent FDA warning letters over unauthorized COVID-19 tests. What did these tests have in common?
Update on emergency use authorization for third SARS-CoV-2 POC antigen test.
What the National Cancer Institute (NCI) found toward the revocation of Autobio Diagnostics’ antibody test EUA.
New developments in measuring SARS-CoV-2 antibodies.
Overview of new CMS resource for understanding SARS-CoV-2 antigen test distribution to nursing homes.
FDA guidance provides pathway for developers and manufacturers to obtain EUAs for at-home and over-the-counter COVID-19 testing. The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) template for test developers attempting to create at-home and over-the-counter SARS-CoV-2 diagnostic tests. The FDA announced this new template in