Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs) by Glenn S. Demby | Nov 24, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies... This content is for Paid Members only.RegisterAlready a member? Log in here
FDA Imposes New Limits on COVID-19 Tests with Access to EUA Pathway by Glenn S. Demby | Nov 24, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Emerging Tests-dtet... This content is for Paid Members only.RegisterAlready a member? Log in here
CMS Repeals Rule Providing Expedited Medicare Coverage for MCIT “Breakthrough” Devices by Glenn S. Demby | Nov 19, 2021 | Articles, CMS-nir, Essential, Must read, National Lab Reporter... This content is for Paid Members only.RegisterAlready a member? Log in here
Management Expert Report Cites Weaknesses in Agency’s EUA Processes by Glenn S. Demby | Oct 29, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet... This content is for Paid Members only.RegisterAlready a member? Log in here
Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs by Glenn S. Demby | Oct 5, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet... This content is for Paid Members only.RegisterAlready a member? Log in here