FDA Expands Recall of Ellume COVID-19 Home Test Kits by Glenn S. Demby | Nov 19, 2021 | Articles, Essential, FDA-nir, National Lab Reporter... This content is for Paid Members only.Login Register
Agency Takes Steps to Promote Scientifically Sound Development of AI-Based Medical Devices by Glenn S. Demby | Nov 4, 2021 | Articles, Essential, FDA-lir, Laboratory Industry Report... This content is for Paid Members only.Login Register
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.Login Register
FDA Requires EUA SARS-CoV-2 Test Developers to Account for Viral Mutations 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.Login Register
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.Login Register