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
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
Biden Pulls Plug on Automatic Medicare Coverage for MCIT “Breakthrough” Devices by Glenn S. Demby | Sep 23, 2021 | Articles, Essential, National Lab Reporter, Reimbursement-nir... This content is for Paid Members only.Login Register
Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs by Glenn S. Demby | Sep 13, 2021 | Articles, Essential, FDA-lir, Laboratory Industry Report, LDTs-lir... This content is for Paid Members only.Login Register
Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees by Glenn S. Demby | Sep 6, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet... This content is for Paid Members only.Login Register